LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

The LED Light Therapy Mask is an over-the-counter device that uses light-emitting diodes (LEDs) in red, blue, and infrared wavelengths to treat facial wrinkles and mild to moderate acne. Users wear the mask over their face for approximately 10 minutes per session, 3 times per week, with an integrated eye shield to protect against LED light exposure.

The device uses LEDs at red (620nm±10nm), blue (460±10nm), and infrared (850nm±10nm) wavelengths with varying intensity levels depending on model. It incorporates a protective eye shield to block light from reaching the eyes. Some models include a wireless controller for operation, while others are standalone units. LED intensity ranges from 2.0–10 mW/cm² depending on the specific model and mode.

The device was tested to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57 (non-laser light source equipment), IEC 62471 (photobiological safety), IEC 62133-2 (lithium battery safety), and biocompatibility standards ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation).

The subject device has the same intended use (LED light treatment for wrinkles and mild-to-moderate acne), same regulatory classification (Class II, product codes OHS and OLP), and similar technological characteristics (LED wavelengths, intensity, and form factor) as the predicate and reference devices. Minor differences in power supply specifications and LED intensity are not raised as safety or effectiveness concerns because the subject device's intensity falls between predicate and reference devices and all electrical and biocompatibility testing passed relevant standards. The comparable design, materials (ABS and silicone), and treatment protocols establish functional equivalence.