[
  {
    "brand": "Omnilux",
    "model": "Contour Face",
    "name": "Omnilux Contour Face",
    "slug": "omnilux-contour-face",
    "category": "ranked",
    "price_usd": 395.0,
    "price_source": "omniluxled.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "All Omnilux devices have been FDA cleared, TGA approved, and CE certified",
    "claim_source": "omniluxled.com (help center + product pages)",
    "k_number": "K191629",
    "k_holder": "Ismart Marketing Svcs, Ltd.",
    "k_device_name": "faceLITE",
    "k_date": "2019-09-12",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS)",
    "wavelengths": "633 nm red · 830 nm near-infrared",
    "verdict": "cleared-oem",
    "headline_claim": "“All Omnilux devices have been FDA cleared” — the K-number on file is K191629, a 2019 clearance for a device named faceLITE, held by Ismart Marketing Svcs, Ltd.",
    "verdict_note": "The clearance is real — and it is not Omnilux's. FDA's registration & listing database shows “Omnilux Contour” listed under K191629, a 510(k) granted in September 2019 to Ismart Marketing Svcs, Ltd. of Birmingham, UK, for a device named faceLITE. The same I-SMART listing carries eighteen other brand names — PRIORI, faceLITE, Smoothskin DuoLux, Glo mask, Deesse Pro Express, City Beauty's mask and more — and CurrentBody's parent, The Beauty Tech Group, lists “Omnilux contour” under the same K-number. Riding a licensor's clearance is legal and common; the record simply says the paper behind the best-known mask in the category names a different device and a different company.",
    "sources": [
      {
        "name": "FDA 510(k) K191629 — faceLITE, Ismart Marketing Svcs (2019)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191629"
      },
      {
        "name": "FDA registration & listing — “Omnilux Contour” under K191629 (openFDA index)",
        "url": "https://open.fda.gov/apis/device/registrationlisting/"
      },
      {
        "name": "Omnilux — Contour Face product page (price, wavelengths)",
        "url": "https://omniluxled.com/products/omnilux-contour-face"
      },
      {
        "name": "Omnilux — help center (“All Omnilux devices have been FDA cleared”)",
        "url": "https://omniluxled.com/pages/help-center"
      }
    ],
    "amazon_search": "omnilux contour face led mask",
    "brand_url": "https://omniluxled.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "CurrentBody",
    "model": "Skin LED Series 2 (MK-90H)",
    "name": "CurrentBody Skin LED Mask Series 2",
    "slug": "currentbody-skin-led-series-2",
    "category": "ranked",
    "price_usd": 469.99,
    "price_source": "us.currentbody.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "FDA cleared LED face mask for advanced anti-aging",
    "claim_source": "us.currentbody.com product page (the same page's certification field reads “UKCA registered”)",
    "k_number": "K250966",
    "k_holder": "Shenzhen Kaiyan Medical Equipment Co., Ltd",
    "k_device_name": "CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)",
    "k_date": "2025-06-25",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS)",
    "wavelengths": "633 nm red · 830 nm near-infrared · 1072 nm deep near-infrared",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA cleared LED face mask for advanced anti-aging” — K250966 names the Series 2 itself, filed and held by Shenzhen Kaiyan Medical, CurrentBody's manufacturer",
    "verdict_note": "The cleanest OEM row in the table: K250966 (June 2025) names the exact product — “CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)” — so there is no name gap, but the applicant and holder is Shenzhen Kaiyan Medical Equipment Co., the contract manufacturer, not CurrentBody. One detail worth reading twice on the product page: the specification block's certification field says “UKCA registered” while the heading says “FDA cleared” — both can be true; they are different registers in different countries. CurrentBody's own earlier masks rode Light Tree Ventures' K221775, and its parent company also lists Omnilux Contour — see the OEM guide for the family tree.",
    "sources": [
      {
        "name": "FDA 510(k) K250966 — CurrentBody Skin LED Series 2, Shenzhen Kaiyan (2025)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250966"
      },
      {
        "name": "CurrentBody US — Series 2 product page (claim, price, wavelengths, “UKCA registered” field)",
        "url": "https://us.currentbody.com/products/currentbody-skin-led-light-therapy-face-mask-series-2"
      }
    ],
    "amazon_search": "currentbody skin led mask series 2",
    "brand_url": "https://us.currentbody.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "Shark",
    "model": "CryoGlow FW312",
    "name": "Shark CryoGlow",
    "slug": "shark-cryoglow",
    "category": "ranked",
    "price_usd": 349.99,
    "price_source": "sharkninja.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "The product has been FDA cleared as safe and effective for treatment of fine lines and acne.",
    "claim_source": "sharkninja.com FW312 product page",
    "k_number": "K242796",
    "k_holder": "SharkNinja Operating, LLC",
    "k_device_name": "CryoGlow (FW3XXXX)",
    "k_date": "2024-11-27",
    "k_codes": "OHS (listing adds OLP)",
    "cleared_for": "Wrinkles (OHS) · acne per OLP listing",
    "wavelengths": "630 nm red · 830 nm infrared · blue (nm as published on page)",
    "verdict": "cleared-brand",
    "headline_claim": "“FDA cleared as safe and effective for treatment of fine lines and acne” — K242796 is held by SharkNinja itself, one of two mass-market brands in the table that filed under its own name",
    "verdict_note": "SharkNinja filed K242796 in its own name in November 2024, covering the CryoGlow family (FW3XXXX), and its FDA listing carries both the wrinkle (OHS) and acne (OLP) product codes — the claim on the box and the paper behind it have the same name on them. Contract manufacturers in Vietnam and China appear in the listing index without their own K-numbers, which is the normal shape of a brand-held clearance. MAUDE adverse-event reports exist for this device, as they do for other masks in the table — reports are indexed, not judged, in our eye-safety guide.",
    "sources": [
      {
        "name": "FDA 510(k) K242796 — CryoGlow, SharkNinja Operating (2024)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242796"
      },
      {
        "name": "Shark — CryoGlow FW312 product page (claim, price)",
        "url": "https://www.sharkninja.com/shark-cryoglow-red-blue-infrared-iqled-face-mask-under-eye-cooling---blue-frost/FW312.html"
      },
      {
        "name": "FDA MAUDE — example adverse-event report, Shark CryoGlow",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21739118&pc=OHS"
      }
    ],
    "amazon_search": "shark cryoglow led face mask",
    "brand_url": "https://www.sharkninja.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "Solawave",
    "model": "Wrinkle Retreat (page sells “Pro”)",
    "name": "Solawave Wrinkle Retreat",
    "slug": "solawave-wrinkle-retreat",
    "category": "ranked",
    "price_usd": 399.0,
    "price_source": "solawave.co product page",
    "price_date": "2026-07-16",
    "fda_claim": "FDA Cleared, 320 LEDS, 4 Wavelengths",
    "claim_source": "solawave.co Wrinkle Retreat product page",
    "k_number": "K221775",
    "k_holder": "Light Tree Ventures Europe B.V.",
    "k_device_name": "LED Light Therapy Mask (MK-78, MK-04, MK66-H, MK66R-B, EL00003)",
    "k_date": "2022-12-20",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS)",
    "wavelengths": "605 nm amber · 630 nm red · 660 nm deep red · 830 nm near-infrared",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA Cleared, 320 LEDS, 4 Wavelengths” — the FDA listing for “Solawave Wrinkle Retreat Light Therapy Face Mask” rides K221775, Light Tree Ventures' 2022 generic-mask clearance",
    "verdict_note": "FDA's listing index maps “Solawave Wrinkle Retreat Light Therapy Face Mask” to K221775 — a December 2022 clearance held by Light Tree Ventures Europe B.V. for a device named, in full, “LED Light Therapy Mask” across five model numbers. Two things are worth knowing. First, the paper is an OEM's, filed years before Solawave's mask launched under it — legal, common, and invisible from the box. Second, the page we checked now sells a “Wrinkle Retreat Pro” (320 LEDs, 4 wavelengths); the name in the FDA listing is the non-Pro mask, and no listing under the Pro name surfaced in the public index when we checked. If Solawave publishes the Pro's own listing or K-number, this row changes — the record wins. Solawave's other devices sit on different paper: the 4-in-1 wand on K232863, the 2-in-1 Mini on K250532, both filed by Shenzhen Kaiyan.",
    "sources": [
      {
        "name": "FDA 510(k) K221775 — LED Light Therapy Mask, Light Tree Ventures (2022)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221775"
      },
      {
        "name": "Solawave — Wrinkle Retreat product page (claim, price, wavelengths)",
        "url": "https://www.solawave.co/products/wrinkle-retreat-light-therapy-face-mask"
      },
      {
        "name": "FDA 510(k) K250532 — Solawave 2-in-1 Skincare Mini, filed by Shenzhen Kaiyan (2025)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250532"
      }
    ],
    "amazon_search": "solawave wrinkle retreat led face mask",
    "brand_url": "https://www.solawave.co/",
    "checked": "2026-07-16"
  },
  {
    "brand": "LightStim",
    "model": "for Wrinkles",
    "name": "LightStim for Wrinkles",
    "slug": "lightstim-for-wrinkles",
    "category": "ranked",
    "price_usd": 249.0,
    "price_source": "lightstim.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "LightStim for Wrinkles is FDA Cleared to treat wrinkles on the entire face.",
    "claim_source": "lightstim.com product page",
    "k_number": "K120775",
    "k_holder": "LED Intellectual Properties, LLC",
    "k_device_name": "LIGHT FOR WRINKLES",
    "k_date": "2012-06-04",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS)",
    "wavelengths": "Amber, light red, dark red, infrared — nm not published on the product page",
    "verdict": "cleared-brand",
    "headline_claim": "“FDA Cleared to treat wrinkles on the entire face” — K120775 (2012) is held by LED Intellectual Properties, LightStim's own IP entity: fourteen years of brand-held paper",
    "verdict_note": "The oldest paper in the ranking, and it belongs to the brand: LED Intellectual Properties, LLC — LightStim's IP arm — has held OHS clearances since 2010 (K101190) with K120775 covering the wrinkle device in 2012, and later filings for the professional panels and the acne device. It is a handheld wand-style panel rather than a wearable mask, which is also why it is the cheapest verified row in the table. One honest gap: the product page names its four light colors but publishes no nanometer values — the only ranked row without printed wavelengths.",
    "sources": [
      {
        "name": "FDA 510(k) K120775 — Light for Wrinkles, LED Intellectual Properties (2012)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120775"
      },
      {
        "name": "LightStim — for Wrinkles product page (claim, price)",
        "url": "https://lightstim.com/products/lightstim-for-wrinkles"
      }
    ],
    "amazon_search": "lightstim for wrinkles",
    "brand_url": "https://lightstim.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "Qure",
    "model": "Q-Rejuvalight Pro (P19-0023)",
    "name": "Qure Q-Rejuvalight Pro",
    "slug": "qure-q-rejuvalight-pro",
    "category": "ranked",
    "price_usd": 295.26,
    "price_source": "qureskincare.com (reg. $399, sale price)",
    "price_date": "2026-07-16",
    "fda_claim": "the world's first customizable, FDA-cleared at-home LED device designed for the treatment of wrinkles and mild-to-moderate inflammatory acne",
    "claim_source": "qureskincare.com product page",
    "k_number": "K230042",
    "k_holder": "Light Tree Ventures Europe B.V.",
    "k_device_name": "Q-Rejuvalight Pro Facewear (Model: P19-0023)",
    "k_date": "2023-04-28",
    "k_codes": "OHS (listing adds OLP)",
    "cleared_for": "Wrinkles (OHS) · acne per OLP listing",
    "wavelengths": "415 nm blue · 605 nm amber · 630 nm red · 660 nm deep red · 880 nm infrared",
    "verdict": "cleared-oem",
    "headline_claim": "“The world's first customizable, FDA-cleared at-home LED device” — K230042 names the Q-Rejuvalight Pro itself, but the holder is Light Tree Ventures, not Qure",
    "verdict_note": "K230042 (April 2023) names the exact product — “Q-Rejuvalight Pro Facewear (Model: P19-0023)” — so the claim maps cleanly to a real clearance. The holder is Light Tree Ventures Europe B.V., the OEM whose paper also sits behind Solawave's Wrinkle Retreat and the LUSTRE and myLEDmask lines; Qure itself appears nowhere in the 510(k) index. The listing carries both wrinkle and acne product codes, matching the two-part marketing claim. The “world's first customizable” half of the sentence is a marketing superlative outside any FDA record — the record neither supports nor contradicts it, and we don't rank superlatives.",
    "sources": [
      {
        "name": "FDA 510(k) K230042 — Q-Rejuvalight Pro Facewear, Light Tree Ventures (2023)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230042"
      },
      {
        "name": "Qure — Q-Rejuvalight Pro product page (claim, price, wavelengths)",
        "url": "https://qureskincare.com/products/q-rejuvalight-pro-facewear"
      }
    ],
    "amazon_search": "qure q-rejuvalight pro led mask",
    "brand_url": "https://qureskincare.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "HigherDOSE",
    "model": "Red Light Face Mask (MK66-L)",
    "name": "HigherDOSE Red Light Face Mask",
    "slug": "higherdose-red-light-face-mask",
    "category": "ranked",
    "price_usd": 349.0,
    "price_source": "higherdose.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "FDA-cleared",
    "claim_source": "higherdose.com product page (title and description)",
    "k_number": "K241933",
    "k_holder": "Shenzhen Kaiyan Medical Equipment Co., Ltd",
    "k_device_name": "HIGHERDOSE Red and Infrared Light Mask (MK66-L)",
    "k_date": "2024-09-27",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS)",
    "wavelengths": "630 nm red (26 mW/cm²) · 830 nm near-infrared (24 mW/cm²)",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA-cleared” — K241933 names the HigherDOSE mask, filed and held by Shenzhen Kaiyan; the model number, MK66-L, places it in the same MK66 family as masks sold under other brands",
    "verdict_note": "K241933 (September 2024) names the product — “HIGHERDOSE Red and Infrared Light Mask” — with Shenzhen Kaiyan Medical as applicant and holder. The model number is the tell: MK66-L sits in the same MK66 series as the MK66-H and MK66R-B cleared under Light Tree Ventures' K221775 — the molds behind several differently-branded masks in this category are siblings, which is exactly the kind of fact the box never states. HigherDOSE is one of the few brands publishing per-wavelength irradiance (26/24 mW/cm²) on the product page. Its other wellness products (sauna mats, the no-K infrared listings) sit outside the mask record — see the panels guide for why that side of the catalog doesn't need clearance.",
    "sources": [
      {
        "name": "FDA 510(k) K241933 — HIGHERDOSE Red and Infrared Light Mask, Shenzhen Kaiyan (2024)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241933"
      },
      {
        "name": "HigherDOSE — Red Light Face Mask product page (claim, price, irradiance)",
        "url": "https://higherdose.com/products/red-light-face-mask"
      }
    ],
    "amazon_search": "higherdose red light face mask",
    "brand_url": "https://higherdose.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "Therabody",
    "model": "TheraFace Mask",
    "name": "Therabody TheraFace Mask",
    "slug": "therabody-theraface-mask",
    "category": "ranked",
    "price_usd": 649.99,
    "price_source": "therabody.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "FDA cleared",
    "claim_source": "therabody.com product page",
    "k_number": "K230293",
    "k_holder": "Therabody, Inc.",
    "k_device_name": "TheraFace Mask",
    "k_date": "2023-06-09",
    "k_codes": "OHS (listing adds OLP)",
    "cleared_for": "Wrinkles (OHS) · acne per OLP listing",
    "wavelengths": "633 nm red · 830 nm infrared · 415 nm blue",
    "verdict": "cleared-brand",
    "headline_claim": "“FDA cleared” — K230293 is held by Therabody itself and names the TheraFace Mask: brand-held paper, and the most expensive verified row in the table",
    "verdict_note": "Therabody filed K230293 in its own name in June 2023, naming the TheraFace Mask exactly; the listing carries both wrinkle and acne codes, and earlier TheraFace attachments (K212155, K212238) show the company has been filing its own paper since 2021. Nothing in the record distinguishes its clearance from a $349 competitor's — a 510(k) is a safety-and-equivalence review, not a performance ranking, which is worth remembering at $649.99. The vibration/massage features sit outside the light-therapy record entirely.",
    "sources": [
      {
        "name": "FDA 510(k) K230293 — TheraFace Mask, Therabody (2023)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230293"
      },
      {
        "name": "Therabody — TheraFace Mask product page (claim, price, wavelengths)",
        "url": "https://www.therabody.com/products/theraface-mask"
      }
    ],
    "amazon_search": "theraface mask therabody",
    "brand_url": "https://www.therabody.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "FOREO",
    "model": "FAQ 202",
    "name": "FOREO FAQ 202",
    "slug": "foreo-faq-202",
    "category": "unranked",
    "price_usd": null,
    "price_source": "no first-party USD price verifiable (foreo.com geo-serves non-US pricing)",
    "price_date": "2026-07-16",
    "fda_claim": "No FDA language found on the official product page we could reach (geo-served); the clearance itself is real and brand-held",
    "claim_source": "foreo.com (checked 2026-07-16)",
    "k_number": "K240378",
    "k_holder": "Foreo, Inc.",
    "k_device_name": "FAQ 201, FAQ 202",
    "k_date": "2024-04-19",
    "k_codes": "OHS (listing adds OLP)",
    "cleared_for": "Wrinkles (OHS) · acne per OLP listing",
    "wavelengths": "8 published wavelengths incl. 650 nm red · 850 nm NIR · 465 nm blue",
    "verdict": "cleared-brand",
    "headline_claim": "The quietest paper in the index: K240378 is brand-held and names the FAQ 202 exactly — and the official page we reached barely mentions it",
    "verdict_note": "Foreo filed K240378 in its own name in April 2024, naming FAQ 201 and FAQ 202; a second brand-held clearance (K253683) covers the FAQ LED panels. The row is unranked for one reason only: foreo.com geo-serves regional pricing and we could not verify a first-party USD price — no verified price, no rank, the same rule every row gets. The clearance status itself is among the cleanest in the category.",
    "sources": [
      {
        "name": "FDA 510(k) K240378 — FAQ 201/202, Foreo (2024)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240378"
      },
      {
        "name": "FOREO — FAQ 202 product page",
        "url": "https://www.foreo.com/faq-swiss-202"
      }
    ],
    "amazon_search": null,
    "brand_url": "https://www.foreo.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "MZ Skin",
    "model": "LightMAX Supercharged LED Mask 2.0",
    "name": "MZ Skin LightMAX 2.0",
    "slug": "mz-skin-lightmax-2",
    "category": "unranked",
    "price_usd": null,
    "price_source": "no first-party USD price (mzskin.com lists £750 GBP only)",
    "price_date": "2026-07-16",
    "fda_claim": "Our LightMAX Supercharged LED Mask 2.0 is FDA cleared (medical grade).",
    "claim_source": "mzskin.com product page",
    "k_number": "K213184",
    "k_holder": "MZ Skin (filed via iSMART — the 510(k) correspondent is iSMART's owner)",
    "k_device_name": "MZ Skin LightMAX Supercharged LED Mask 2.0",
    "k_date": "2021-11-23",
    "k_codes": "OLP (listing adds OHS)",
    "cleared_for": "Acne (OLP) · wrinkles per OHS listing",
    "wavelengths": "633 nm red · 830 nm near-infrared · 415 nm blue",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA cleared (medical grade)” — K213184 names the mask; the 510(k) paperwork itself is signed by iSMART, the same UK constellation behind Omnilux Contour's faceLITE paper",
    "verdict_note": "K213184 (November 2021) names the LightMAX 2.0 exactly, with MZ Skin as applicant — but the clearance correspondence is signed by the owner of iSMART, and FDA's listing index files the mask under I-SMART Development Ltd., the same Birmingham constellation whose faceLITE clearance (K191629) sits behind Omnilux Contour, PRIORI, Deesse and a dozen other names. “Medical grade” is a marketing phrase with no FDA definition — the record says Class II, 510(k)-cleared, like every other mask in this table. Unranked only because mzskin.com publishes GBP pricing (£750) and no first-party USD price: no verified price, no rank.",
    "sources": [
      {
        "name": "FDA 510(k) K213184 — MZ Skin LightMAX 2.0 (2021; correspondent: iSMART)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213184"
      },
      {
        "name": "FDA 510(k) K213184 decision PDF (iSMART correspondence on page 1)",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213184.pdf"
      },
      {
        "name": "MZ Skin — LightMAX 2.0 product page (claim, GBP price, wavelengths)",
        "url": "https://www.mzskin.com/products/led-face-mask-lightmax-supercharged"
      }
    ],
    "amazon_search": null,
    "brand_url": "https://www.mzskin.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "The Light Salon",
    "model": "Boost LED Face Mask (+ Boost Advanced)",
    "name": "The Light Salon Boost",
    "slug": "the-light-salon-boost",
    "category": "unranked",
    "price_usd": null,
    "price_source": "no first-party USD price (thelight-salon.com lists £395 GBP; US retailers carry it, but the rule is first-party)",
    "price_date": "2026-07-16",
    "fda_claim": "FDA-Cleared for treating fine lines & wrinkles",
    "claim_source": "thelight-salon.com Boost LED Face Mask product page; the brand's Boost FAQ cites “510(K) No. K191629” by number — rare candour in this category",
    "k_number": "K191629",
    "k_holder": "Ismart Marketing Svcs, Ltd. (original Boost); the newer Boost Advanced is listed under Light Tree Ventures' K221775",
    "k_device_name": "faceLITE (K191629) · LED Light Therapy Mask (K221775)",
    "k_date": "2019-09-12",
    "k_codes": "OHS (Boost Advanced listing adds OLP via K221775)",
    "cleared_for": "Wrinkles (OHS) · Boost Advanced listed for acne too (OLP)",
    "wavelengths": "633 nm red · 830 nm near-infrared (56 + 56 LEDs)",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA-Cleared for treating fine lines & wrinkles” — true twice over: the original Boost is listed under K191629 (Ismart's faceLITE, Omnilux Contour's paper) and the Boost Advanced under Light Tree's K221775 (Solawave's paper). One brand, both OEM constellations.",
    "verdict_note": "The clearest single exhibit of how this category's paper actually works. FDA's listing index shows The Light Salon's masks riding both of the record's big constellations: the original “Light Salon Boost” sits under K191629 — the 2019 faceLITE clearance held by Ismart Marketing, the same paper behind Omnilux Contour (The Beauty Tech Group lists both names in one entry) — while the newer “Boost Advanced LED Face Mask” is listed under K221775, Light Tree Ventures' generic-mask clearance, the same paper behind Solawave's Wrinkle Retreat, with Shenzhen Kaiyan appearing as a lister. Both clearances are real; neither is The Light Salon's own. The same brand's “LED Bib” neck piece sits on an ILY infrared-lamp listing with no K-number at all — the exact pattern our panels guide describes. A MAUDE adverse-event report exists for the Boost Advanced, as for other cleared masks in the table. Unranked for one reason: thelight-salon.com publishes GBP pricing and no first-party USD price — no verified price, no rank, the same rule every row gets.",
    "sources": [
      {
        "name": "FDA 510(k) K191629 — faceLITE, Ismart Marketing Svcs (2019): the original Boost's listed paper",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191629"
      },
      {
        "name": "FDA 510(k) K221775 — LED Light Therapy Mask, Light Tree Ventures (2022): the Boost Advanced's listed paper",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221775"
      },
      {
        "name": "openFDA registration & listing — “Light Salon Boost” under K191629; “Boost The Light Salon Advanced LED Face Mask” under K221775 (checked 2026-07-16)",
        "url": "https://open.fda.gov/apis/device/registrationlisting/"
      },
      {
        "name": "The Light Salon — Boost LED Face Mask product page (claim, £395, wavelengths, LED counts)",
        "url": "https://www.thelight-salon.com/products/boost-led-face-mask"
      },
      {
        "name": "FDA MAUDE — adverse-event report, Boost Advanced LED Light Therapy Face Mask",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9793147&pc=OHS"
      },
      {
        "name": "The Light Salon — Boost FAQs (cites 510(K) No. K191629)",
        "url": "https://www.thelight-salon.com/pages/boost-faqs"
      }
    ],
    "amazon_search": null,
    "brand_url": "https://www.thelight-salon.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "Dr. Dennis Gross",
    "model": "DRx SpectraLite FaceWare Pro",
    "name": "Dr. Dennis Gross SpectraLite FaceWare Pro",
    "slug": "dr-dennis-gross-spectralite",
    "category": "below-line",
    "below_label": "Claim unmatched in the public index",
    "price_usd": 455.0,
    "price_source": "drdennisgross.com product page",
    "price_date": "2026-07-16",
    "fda_claim": "This device is FDA Cleared!",
    "claim_source": "drdennisgross.com product page",
    "k_number": null,
    "k_holder": null,
    "k_device_name": null,
    "k_date": null,
    "k_codes": null,
    "cleared_for": "— no matching record found under the names we checked",
    "wavelengths": "415 nm blue · 605 nm amber · 630 nm red · 880 nm near-infrared",
    "verdict": "claim-unmatched",
    "headline_claim": "“This device is FDA Cleared!” — no 510(k) or FDA listing under the Dr. Dennis Gross or FaceWare names surfaced in the public index; the only “SpectraLite” in the record is LED Technologies' 2017 dpl SpectraLite (K171386)",
    "verdict_note": "We could not match this claim to its paper. Searching FDA's 510(k) database and registration & listing index found no clearance or device listing under “Dr. Dennis Gross,” “DRx,” “FaceWare,” or “SpectraLite” as marketed — the only SpectraLite in the federal record is K171386, “dpl SpectraLite,” cleared in 2017 to LED Technologies, Inc., the company whose dpl and reVive lines pioneered this category. A shared name across a licensing deal would be unsurprising and entirely legal — but unlike every ranked row, no public record we searched connects this specific product to a K-number. This is a statement about the public index, not about the device: if the brand publishes its K-number, this row moves the same day. Until then: no matched record, no rank, no purchase link.",
    "sources": [
      {
        "name": "FDA 510(k) K171386 — dpl SpectraLite, LED Technologies (2017): the only “SpectraLite” in the record",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171386"
      },
      {
        "name": "Dr. Dennis Gross — DRx SpectraLite FaceWare Pro product page (claim, price)",
        "url": "https://drdennisgross.com/products/drx-spectralite-faceware-pro"
      },
      {
        "name": "FDA 510(k) database — search it yourself",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm"
      }
    ],
    "amazon_search": null,
    "brand_url": "https://drdennisgross.com/",
    "checked": "2026-07-16"
  },
  {
    "brand": "VogueNow",
    "model": "LED Light Therapy Mask (Amazon)",
    "name": "VogueNow LED Mask",
    "slug": "voguenow-led-mask",
    "category": "below-line",
    "below_label": "Amazon tier — model-scope unclear",
    "price_usd": null,
    "price_source": "Amazon-only brand; no first-party price surface",
    "price_date": "2026-07-16",
    "fda_claim": "FDA-Cleared Device for Wrinkles & Acne",
    "claim_source": "Amazon listing title (B0FV3NBRCB)",
    "k_number": "K243423",
    "k_holder": "Shenzhen Rainbow Technology Co., Ltd.",
    "k_device_name": "LED Light Therapy Mask (RB-008, RB-030, RB-081, …)",
    "k_date": "2025-01-28",
    "k_codes": "OHS",
    "cleared_for": "Wrinkles (OHS) — for the listed models",
    "wavelengths": "Red, blue, near-infrared per listing — nm in listing copy only",
    "verdict": "cleared-oem",
    "headline_claim": "An Amazon-native brand whose “FDA-Cleared” title does map to real paper — Shenzhen Rainbow's K243423 — but to model numbers the Amazon listing never states",
    "verdict_note": "The representative Amazon-tier row. FDA's listing index maps “VogueNow LuminX Pro (RB-008G)” to K243423, a January 2025 clearance held by Shenzhen Rainbow Technology for its RB-series masks — so the brand's FDA language is not invented. What the Amazon listing never states is which model you receive and whether it is one of the cleared RB numbers; the title says “Wrinkles & Acne” while the matched K covers the wrinkle code. No first-party site, no first-party price, model-scope unstated: everything about the row is checkable except the thing you'd actually buy. That is the Amazon tier in one sentence, and why it sits below the line without a purchase link.",
    "sources": [
      {
        "name": "FDA 510(k) K243423 — LED Light Therapy Mask (RB-series), Shenzhen Rainbow (2025)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243423"
      },
      {
        "name": "Amazon — VogueNow LED mask listing (claim in title)",
        "url": "https://www.amazon.com/VogueNow-LED-Light-Therapy-Mask/dp/B0FV3NBRCB"
      }
    ],
    "amazon_search": null,
    "brand_url": null,
    "checked": "2026-07-16"
  },
  {
    "brand": "Aphrona",
    "model": "MOONLIGHT PRO (Amazon)",
    "name": "Aphrona MOONLIGHT PRO",
    "slug": "aphrona-moonlight-pro",
    "category": "below-line",
    "below_label": "Amazon tier — indication-scope gap",
    "price_usd": null,
    "price_source": "Amazon-only surface; no first-party price verified",
    "price_date": "2026-07-16",
    "fda_claim": "Aphrona FDA cleared LED Facial Mask MOONLIGHT PRO … for Acne Removal Wrinkle Reduction",
    "claim_source": "Amazon listing title (B07Z4HDZGW)",
    "k_number": "K192295",
    "k_holder": "Beijing ADSS Development Co., Ltd.",
    "k_device_name": "PDT-FACE",
    "k_date": "2020-05-01",
    "k_codes": "OLP",
    "cleared_for": "Acne (OLP) — the matched record; the wrinkle half of the title has no matched K",
    "wavelengths": "7-color LED per listing — nm in listing copy only",
    "verdict": "cleared-oem",
    "headline_claim": "“FDA cleared … for Acne Removal Wrinkle Reduction” — the matched record (Beijing ADSS's K192295, device name PDT-FACE) is an acne clearance; the wrinkle half of the title outruns the matched paper",
    "verdict_note": "FDA's listing index maps “Aphrona LED facial mask” to K192295 — a May 2020 acne-code (OLP) clearance held by Beijing ADSS Development for a device named PDT-FACE. The Amazon title sells both “Acne Removal” and “Wrinkle Reduction”; the matched record covers the first. A wrinkle-code clearance may exist under another name — the index is searchable and we say only what it showed on the check date. Until a wrinkle-code record is matched, the title claims more indications than the paper we can find: the cleanest example in the table of an indication-scope gap, which is a different failure mode than a fake claim.",
    "sources": [
      {
        "name": "FDA 510(k) K192295 — PDT-FACE, Beijing ADSS Development (2020, acne/OLP)",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192295"
      },
      {
        "name": "Amazon — Aphrona MOONLIGHT PRO listing (claim in title)",
        "url": "https://www.amazon.com/cleared-Aphrona-Facial-Treatment-Photon/dp/B07Z4HDZGW"
      }
    ],
    "amazon_search": null,
    "brand_url": null,
    "checked": "2026-07-16"
  }
]