LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

The LED Therapy Mask is an over-the-counter, home-use wearable LED phototherapy device consisting of a mask, controller, USB charging cable, and head strap. It emits red (630nm), infrared (830nm), yellow (590nm), and blue (415nm) light from LEDs to treat mild-to-moderate inflammatory acne and full-face wrinkles in three modes: ACNE (red + blue), FIRM (yellow), and WRINKLE (red + IR). The device is powered by a rechargeable lithium battery and automatically shuts down after the treatment time expires.

The subject device and predicates all use LEDs as the light source, employ a full-face mask design, and utilize the same four wavelengths (630nm, 830nm, 590nm, 415nm). Key differences include: lithium battery tested to IEC 62133-2; slightly different dimensions; light irradiance values (70 mW/cm² for ACNE mode, 124 mW/cm² for WRINKLE mode, 20 mW/cm² for FIRM mode) that fall between predicate values; and a 10-minute treatment time between predicates. None of these differences raise safety or effectiveness concerns.

IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-11 (home healthcare environment), IEC 62471 (photobiological safety), IEC 60601-2-83 (home light therapy equipment), IEC 60601-1-6 (usability), ISO 10993-1 (biocompatibility), and FDA guidance on device software content and human factors engineering.

The subject device is substantially equivalent because it shares the same indications for use (wrinkle and acne treatment), uses identical LED technology with the same wavelengths, and employs the full-face mask form factor as legally marketed predicates. Differences in power supply, dimensions, light irradiance, and treatment time are minor and do not raise safety or effectiveness questions, as irradiance values and treatment times fall within the range of existing cleared predicates. Non-clinical testing confirms compliance with applicable standards supporting substantial equivalence.