Wrinkle Treatment Device (JM1, JM2B)

The Wrinkle Treatment Device (models JM1 and JM2B) is an over-the-counter, wearable light-based mask for home use that treats full-face wrinkles. It emits red (660nm) and infrared (850nm) light from VCSEL (vertical-cavity surface-emitting laser) sources. Model JM1 uses direct button controls, while JM2B uses a connected controller for power and mode adjustments. Both are powered by rechargeable lithium-ion batteries.

JM1 features 136 light sources with 90/100 mWcm² fluence and 260cm² treatment area; JM2B features 140 sources with 40/70/100 mWcm² fluence and 330cm² treatment area. Key difference from the predicate: subject device uses VCSEL technology instead of LED. JM1 includes PC in materials (JM2B matches predicate materials exactly). Wavelengths, power supply, intended location, and overall form factor remain comparable to the predicate JM2.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation); IEC 60601-1:2020 (medical electrical equipment safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2020 (home healthcare environment), IEC 60825-1:2014 (laser safety). Software validation per Basic Documentation level and usability per FDA's Human Factors guidance (February 2016).

The device shares identical intended use (OTC treatment of full-face wrinkles), same regulatory class (II), same mask design, and comparable wavelengths and fluence ranges with the predicate JM2. Although the subject uses VCSEL technology rather than LED, bench testing and thermal performance evaluation demonstrate comparable fluence magnitude, distribution, and spatio-temporal temperature profiles. Biocompatibility, electrical safety, EMC, and software validation testing all support that safety and efficacy profiles match the predicate despite the technological difference in light source type.