Product Information
Availability
In Stock
Seller
xueyishi
About this item
- Indications for Use – Red light for full-face wrinkles; blue light for mild to moderate inflammatory acne; infrared light for topical heating, temporary relief of minor pain, muscle relaxation, and improved circulation; mixed light for acne care.
- Wavelengths – Equipped with 620nm red light, 460nm blue light, 850nm infrared light, and a combined mixed light mode.
- Design – Home-use wearable LED mask system, including mask, controller, adapter, USB cable, and straps for convenient application.
- Regulatory Classification – FDA Class II device under 21 CFR 878.4810/890.5500 with product codes OHS, OLP, and ILY.
- Compliance & Safety – Tested to meet IEC 60601 safety standards and ISO 10993 biocompatibility standards; cleared by FDA as substantially equivalent to predicate devices.
