Is the Dr. Dennis Gross SpectraLite FaceWare Pro FDA cleared?

Last reviewed August 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” or “DRx”, and none for “SpectraLite FaceWare Pro” 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; the only Faceware is K183247, “dpl Faceware,” cleared to the same company in 2019 (product code OHS). Both are LED Technologies' own dpl devices. 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

Sources — read the record yourself

• FDA 510(k) K171386 — dpl SpectraLite, LED Technologies (2017): the only “SpectraLite” in the record
• FDA 510(k) K183247 — dpl Faceware, LED Technologies (2019): the only “Faceware” 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.

This page is about the FaceWare Pro face mask. The Dr. Dennis Gross eye device has its own page: Is the Dr. Dennis Gross DRx SpectraLite EyeCare Max Pro FDA cleared? · LED eye devices, ranked by FDA status

Masks whose clearance we could match

Each of these carries a K-number we located in FDA's public database and read. That is a statement about paperwork, not about results — clearance means the device was reviewed as substantially equivalent to one already on the market, not that it will do what the marketing promises.

Several of these clearances are held by an OEM or licensor rather than the brand on the box, which is normal in this category and not a mark against them — who actually holds the paper.

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.

Some product links on this page are affiliate links: as an Amazon Associate we earn from qualifying purchases, at no extra cost to you. Affiliate status never changes a ranking or a verdict — full affiliate disclosure.