Shenzhen Kaiyan Medical Equipment Co., Ltd. · Class II · Cleared Oct 9, 2025
| K-number | K252272 |
| Device name | ORA Method LED Gua Sha (GS-04) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Oct 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The ORA Method LED Gua Sha (GS-04) is a handheld, battery-powered over-the-counter device that emits red (630nm) and infrared (830nm) light to treat facial and decolletage wrinkles. It also includes a vibration function at 200 Hz for massage-like skin relaxation.
The device features a 3.7V 450mAh lithium battery with 20-35 mW/cm² total irradiance, dual LED wavelengths, and a 10-minute recommended treatment duration per area. It includes a charging cable, base, protective goggles, and storage bag.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2 (electrical safety and photobiological safety); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); IEC 62366-1 and IEC 60601-1-6 (usability).
The subject device is substantially equivalent because it shares the same intended use (wrinkle treatment via red and infrared light), same regulatory classification (Class II), similar design principle, comparable wavelengths and irradiance to predicates K250761, K242382, and K242700, and complies with all applicable safety standards despite minor differences in power supply and treatment duration that do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov