LED Light Therapy Device (Models: SG-FM, SG-FE)

The LED Light Therapy Device (Models SG-FM and SG-FE) is an over-the-counter medical device consisting of an LED mask, controller, and charging cable for home use. Model SG-FM treats wrinkles and mild to moderate inflammatory acne using red, amber, blue, and infrared light. Model SG-FE treats wrinkles using red and infrared light, with infrared also providing topical heating to elevate tissue temperature and increase local blood circulation.

Both models use LED energy with wavelengths of 630nm (red), 850nm (infrared), 605nm (amber), and 460nm (blue). The device operates on a 3.7V, 3000mAh lithium-ion rechargeable battery charged via USB cable. Irradiance levels range from 3±20% mW/cm² (850nm) to 22±20% mW/cm² (630nm). Treatment times vary from 10 to 30 minutes depending on light mode. The mask design is similar to the predicate but with slightly different dimensions and battery capacity.

Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-23. Electrical safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-83, IEC 62133-2. Eye safety: IEC 62471. EMC: IEC 60601-1-2. Software verification and validation per FDA guidance.

The subject device is substantially equivalent to predicate K241857 because both use the same LED technology, emit similar wavelengths and irradiance levels, are intended for over-the-counter home use on facial skin for wrinkle treatment and acne, employ identical design principles (mask-based applicators), and meet the same regulatory standards and safety/biocompatibility testing requirements. Differences in dimensions, battery capacity, and treatment time options do not raise new questions of safety or effectiveness.