Light Therapy System (M500, L6)

The Light Therapy System (models M500 and L6) is an over-the-counter, wearable home-use device that emits LED light at four wavelengths (blue 460nm, amber 605nm, red 630nm, and near-infrared 850nm) to treat mild-to-moderate inflammatory acne and facial wrinkles. The device is controlled by an external controller and automatically shuts down after the treatment time expires.

The subject device uses LED technology with wavelengths and intensities similar to predicate devices: blue light (40 mW/cm² for M500, 1.6–3.0 mW/cm² for L6), red+infrared (20 mW/cm² for M500, 1.1–2.0 mW/cm² for L6), and amber (10 mW/cm² for M500, 10.5–11.5 mW/cm² for L6). Treatment time is 10 minutes per session, 3–5 times weekly. Materials include nylon, spandex, PVC leather, and ABS plastic.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation); IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-11:2020 (home healthcare environment), IEC 60601-2-83:2022 (home light therapy equipment), IEC 62471:2006 (photobiological safety).

The Light Therapy System has identical intended uses (treatment of wrinkles and mild-to-moderate acne) and substantially similar technological characteristics (LED wavelengths, intensities, and treatment parameters) to multiple legally marketed predicates including LED masks and light therapy devices. Minor differences in shape (mask vs. handheld panel) and materials do not raise safety or efficacy concerns, as confirmed by biocompatibility, electrical safety, and software validation testing. The device operates on the same fundamental principle and demonstrates comparable performance to predicates across wavelength, power density, and treatment protocol.