Yes. The Solawave Wrinkle Retreat Pro LED mask is FDA-cleared under 510(k) number K252983 — listed in the FDA database with applicant "Shenzhen Goodwind Technology Development Co., Ltd.," device name "Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)," and an FDA decision date of December 17, 2025. Solawave's own site likewise describes the mask as FDA-cleared.
One brand, multiple clearances — match the K number to the product
Solawave sells several devices, and they don't all share one clearance. The database also lists K250532 (applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.; device: "Solawave 2-in-1 Skincare Mini (Model: 61043)"; decided May 22, 2025) — that's the Mini, a different product from the Wrinkle Retreat Pro mask. When verifying, always match the K number to the exact product you're considering.
How to verify it yourself (2 minutes)
- Go to accessdata.fda.gov → 510(k) Premarket Notification database.
- Search K252983 — the K number, not the brand name, since FDA records use the applicant and model designation.
- Confirm applicant ("Shenzhen Goodwind Technology Development Co., Ltd."), device/model ("Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)"), and decision date (December 17, 2025).
For comparison, Photira's entry: K254007, applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, KKS-281.
Price and spec context (as of October 7, 2026)
On solawave.co, the Wrinkle Retreat Pro is listed at $399 (shown as $100 savings off a $499 list price), with a 60-day money-back guarantee and 1-year warranty per the brand. Solawave publishes four wavelengths for the mask — 630 nm red, 830 nm near-infrared, 660 nm deep red, and 605 nm amber — with 65 mW/cm² irradiance (all per the brand's site). Photira's $199 everyday price covers red 630 nm, near-infrared 850 nm, and blue 465 nm, cleared for wrinkles and mild-to-moderate acne under K254007.
Frequently asked questions
What is Solawave's 510(k) number for the LED mask?
K252983 — applicant "Shenzhen Goodwind Technology Development Co., Ltd.," device "Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)," decided December 17, 2025.
Is the Solawave wand or Mini covered by the same clearance?
No. K250532 covers the "Solawave 2-in-1 Skincare Mini (Model: 61043)" (decided May 22, 2025) — a different product with a different applicant. Check the K number per product.
Does FDA-cleared mean FDA-approved?
No. Clearance via the 510(k) pathway means the FDA found the device substantially equivalent to a predicate device. Approval (PMA) is a separate, more extensive review for higher-risk devices.
How much does the Solawave Wrinkle Retreat Pro cost?
$399 on solawave.co as of October 7, 2026 (listed as $100 savings off $499), with a 60-day money-back guarantee and 1-year warranty per the brand.
How can I verify any LED mask's FDA clearance?
Search the K number — not the brand name — in the FDA 510(k) database at accessdata.fda.gov, and confirm applicant, device/model name, and decision date. Example: Photira K254007 (applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, KKS-281).