Is the Solawave Eye Recovery Pro FDA cleared?
Last reviewed October 2026.
Yes. FDA's record ties the Solawave Eye Recovery Pro to a 510(k) clearance, held by a manufacturer or licensor, not by Solawave. Two FDA records name this product. Shenzhen Goodwind's registration lists “Solawave eye recovery pro (Model:PH-e03)”, and K261602 (cleared 10 August 2026) is Goodwind's “Eye Recovery Pro (PH-e03)”. Shenzhen Kaiyan's listing under K233556 (cleared 4 January 2024) also names a “Solawave Eye Recovery Pro”. Both clearances are held by the manufacturer, not by Solawave. The Amazon listing (sold by Solawave's own store) gives no model number. Its LED count and wavelengths (80 LEDs; 605, 630, 660 and 830 nm) are the same as on Solawave's own Eye Recovery Pro page. We cannot tell from the listing which of the two FDA records the unit in the box is filed under. Read in FDA's database on 16 October 2026.
On 8 October 2026 this site said no K-number was matched to the Solawave eye mask yet. The 16 October read found the two records above.
The record on file
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| FDA status | OEM-held K — Cleared — FDA's record ties this product to a K-number held by a manufacturer or licensor |
| 510(k) | K261602 · decided 10 August 2026 · holder Shenzhen Goodwind Technology Development Co., Ltd. · device name “Eye Recovery Pro (PH-e03)” · product code OHS |
| 510(k) | K233556 · decided 4 January 2024 · holder Shenzhen Kaiyan Medical Equipment Co., Ltd. · device name “LED Eye mask (EY-20R, A20, EY-20N)” · product code OHS |
| Cleared for | Light-based over-the-counter wrinkle reduction (product code OHS) |
| The maker's claim | “an FDA-cleared, award-winning hands-free LED eye mask” (solawave.co, Radiant Renewal Eye Recovery Pro product page, read 16 October 2026). |
| Specification | 80 LEDs; 605 nm amber, 630 nm red, 660 nm deep red, 830 nm near-infrared; 3-minute treatment (Amazon listing and Solawave's page, read 16 October 2026; the maker's own figures, not a test) |
| Where to buy | Amazon ↗ sold by the brand's own store (SolaWave), 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.
All four LED eye devices, ranked by FDA status › · Is the CurrentBody LED Eye Perfector FDA cleared? · Is the Dr. Dennis Gross DRx SpectraLite EyeCare Max 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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