Shenzhen Goodwind Technology Development Co., Ltd. · Class II · Cleared Dec 17, 2025
| K-number | K252983 |
| Device name | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) |
| Applicant | Shenzhen Goodwind Technology Development Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Dec 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Wrinkle Retreat Pro Light Therapy Face Mask (Model PH-m03) is an over-the-counter light therapy device designed to treat full-face wrinkles. It uses light-emitting diodes (LEDs) in amber (605nm), red (630nm and 660nm), and near-infrared (830nm) wavelengths applied to the face for 3-minute treatment sessions. The device includes a protective eye-shield and is powered by a rechargeable lithium battery.
The device features 320 LEDs with wavelengths at 605nm±5nm, 630nm±5nm, 660nm±5nm, and 830nm±5nm, delivering 65 mW/cm² total intensity. It uses LED light source technology in a mask form factor with a handheld controller and rechargeable 3.7V lithium battery. Key differences from predicates include higher LED count (320 vs. 80-342) and specific wavelength/intensity specifications, though overall design, form factor, and therapeutic approach remain similar.
Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation). Electrical and safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83 (home light therapy equipment), IEC 62133-2 (lithium battery safety). Eye safety: IEC 62471 (photobiological safety of lamps). Software documentation at basic level with validation testing.
View the full FDA submission: accessdata.fda.gov