LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

This is an LED light therapy mask with 10 different models that emits red (630nm), infrared (850nm), and blue (415nm) light for over-the-counter use. Mode 1 treats full-face wrinkles using red and infrared light; Mode 2 treats mild to moderate inflammatory acne using blue light; and Mode 3 uses mixed light for mild to moderate acne. Models differ in power supply (AC-powered vs. battery-powered), case material (hard plastic vs. silicone gel), and controller design.

The subject device differs from predicate devices in having slightly different wavelengths (blue 415nm vs. 460nm or 465nm; red 630nm vs. 620nm), different power supply options (AC or rechargeable lithium battery vs. predicate's AC-only), and different case materials and controller interfaces. Irradiance levels are similar across all devices (6–8 mW/cm² for red/NIR and 2–4 mW/cm² for blue). All use LED technology with timer and software controls.

IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62471, IEC 62133-2 (electrical safety and electromagnetic compatibility); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); IEC 62366-1 and IEC 60601-1-6 (usability testing).

The subject device is substantially equivalent because it uses the same LED light source technology, targets the same clinical indications (wrinkle treatment and mild-to-moderate acne), operates under the same regulatory classification (Class II, 21 CFR 878.4810), and maintains comparable wavelengths and irradiance levels to predicate devices. Minor differences in wavelength ranges and irradiance are attributed to normal LED manufacturing characteristics and are covered within the predicate devices' specifications; these differences do not raise new safety or effectiveness concerns. The device demonstrates biocompatibility and passes the same design standards as predicates.