FDA 510(k) Cleared LED Face Mask MJ-66B - Medical Grade Silicone

Product Details

FDA 510(k) Cleared LED Face Mask — Medical-Grade Silicone

A FDA-cleared, medical-grade silicone LED face mask engineered for beauty brands, clinics, and private-label programs. Designed to support anti-aging, anti-acne treatment, and collagen stimulation through targeted phototherapy.

Key Features:

- Medical-Grade Silicone construction for comfort and durability

- OEM/ODM Supported — fully customizable for private label programs

- Private Label Available

Technical Specifications:

- LED Array: 66 triple LEDs

- Wavelengths: Blue, Red, and Near-Infrared

- Wavelength Values: 415 / 630 / 830 nm

- Optical Power: 30 mW/cm²

- Treatment Time: 10 minutes per session

- Material: Medical-grade silicone

Certifications & Compliance:

Manufactured under ISO 13485 quality management systems, FDA 510(k) cleared (K221775), and compliant with CE and IEC 60601 standards — meeting the regulatory requirements for global OEM/ODM distribution.

Ideal for beauty brands, aesthetic clinics, and distributors seeking a compliant, science-backed LED phototherapy solution with flexible customization and private-label support.