Light Therapy Mask (1019055)

The Light Therapy Mask (Model 1019055) is a wearable, over-the-counter LED phototherapy device intended for home use to treat full-face wrinkles and mild to moderate inflammatory acne. It consists of a mask body containing red (635nm), blue (465nm), and infrared (850nm) LEDs, a controller with a rechargeable lithium battery, and adjustable straps. The device includes a vibration function for relaxation purposes.

The subject device uses the same LED light source technology and wavelengths as the predicate device (K241857), with comparable irradiance levels (5-20 mW/cm² for individual colors, 10 mW/cm² mixed). Treatment times are similar (5-20 minutes). Both are wearable mask-form factors for facial use. The device meets IEC 60601 electrical safety and biocompatibility standards consistent with predicate devices. Minor differences exist in power supply specifications and treatment mode options.

IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-1:2005 (electrical safety), IEC 60601-1-11:2015 (home healthcare), IEC 60601-2-83:2019 (home light therapy equipment), IEC 62133-2:2017 (lithium battery safety), IEC 62471:2006 (photobiological safety), ISO 10993-5/10/23:2021 (biocompatibility), and FDA guidance on human factors and usability engineering.

The Light Therapy Mask is substantially equivalent to the predicate device (K241857) because it shares the same regulatory classification, intended use (wrinkle and acne treatment), LED technology, wavelengths, and comparable irradiance and treatment parameters. Both are Class II OTC devices regulated under 21 CFR 878.4810. The subject device meets all applicable safety, electrical, biocompatibility, and software validation standards consistent with the predicate, demonstrating equivalent safety and effectiveness for the same indications.