Is the Dr. Dennis Gross SpectraLite FaceWare Pro FDA cleared?
Last reviewed July 2026.
We couldn't match the claim to any K-number — here is exactly what the public record shows. 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.
The record on file
| Verdict | Claim unmatched — FDA claim not matchable to any K-number under the names we checked |
| K-number | None matched under the names we checked (510(k) database + registration & listing index) |
| 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 |
| Price | $455.00 — drdennisgross.com product page |
| The claim | “This device is FDA Cleared!” (drdennisgross.com product page) |
Sources — read the record yourself
- FDA 510(k) K171386 — dpl SpectraLite, LED Technologies (2017): the only “SpectraLite” in the record
- Dr. Dennis Gross — DRx SpectraLite FaceWare Pro product page (claim, price)
- FDA 510(k) database — search it yourself
How to read this
“FDA cleared” means a 510(k): the FDA reviewed the device as substantially equivalent to one already on the market and assigned a K-number you can look up. It is not “FDA approved” (a drug/high-risk standard no LED mask meets), and it is nothing like “FDA registered,” which only means a factory is on a list — the three phrases, decoded. Many real clearances are held by OEMs and licensors rather than the brand on the box — who actually holds the category's paper. A clearance is a safety review, not a results guarantee, and adverse-event reports exist for cleared masks — the eye-safety record.
See every mask we track, claim by claim → · the claims we couldn't match →
LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.
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