Is the Dr. Dennis Gross DRx SpectraLite EyeCare Max Pro FDA cleared?
Last reviewed October 2026.
Not found. We found no 510(k) clearance for the Dr. Dennis Gross DRx SpectraLite EyeCare Max Pro under the names we checked on 16 October 2026. No FDA registration & listing name contains “Dennis Gross”, “DRx”, “SpectraLite” or “EyeCare Max” for a light-therapy device. The only SpectraLite in the 510(k) database is K171386, “dpl SpectraLite”, a 2017 clearance held by LED Technologies, Inc., and none of LED Technologies' 15 clearances is an eye device. This is a statement about the public FDA record on that date, not about the device. If the brand publishes a K-number, this page changes.
The record on file
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| FDA status | Claim unmatched — Marketed as FDA cleared; no matching K-number found under the names we checked |
| 510(k) | None found. Names searched on 16 October 2026: Dennis Gross, DRx, EyeCare, SpectraLite, LED Technologies (applicant). |
| Cleared for | No matching 510(k) found under the names we checked |
| The maker's claim | “Dermatologist-developed and FDA-cleared” (Amazon listing B0BWPJDQB1, first bullet, read 16 October 2026). |
| Specification | 96 LEDs, 4 wavelengths of red light, 3-minute treatment (Amazon listing, read 16 October 2026; the maker's own figures, not a test) |
| Where to buy | See on Amazon ↗ sold by the brand's own store (Dr. Dennis Gross Skincare, LLC), in stock at our 16 October 2026 read. |
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 gave it a K-number you can look up. A 510(k) clearance is a safety and equivalence review, not a results guarantee. It is not FDA approval. Many clearances in this category are held by a manufacturer rather than the brand on the box, which is legal and common — who holds the paper. This page does not say what the device does for the skin around the eyes. Statements about eye safety are the maker's own claims; read the maker's instructions and the eye-safety record for LED masks.
The Dr. Dennis Gross face mask has its own page: Is the Dr. Dennis Gross SpectraLite FaceWare Pro FDA cleared?
All four LED eye devices, ranked by FDA status › · Is the CurrentBody LED Eye Perfector FDA cleared? · Is the Solawave Eye Recovery Pro FDA cleared?
Sources: FDA 510(k) database and registration & listing index, read 16 October 2026; Amazon US buy box, read 16 October 2026 for East Hanover, NJ 07936.
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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