SGROW
Regulatory Classification and Intended Use
The red and blue light beauty mask is classified as a Class II medical device in the United States and can only be marketed after obtaining 510(k) clearance. The red light mask has different expected uses, including wrinkle reduction, acne treatment, and hair removal, depending on parameters such as output power, wavelength, and duration.
Principle of the Beauty Mask
Red light (including infrared light) operates at wavelengths between 615nm and 635nm, primarily affecting epidermal cells. It accelerates metabolism and stimulates collagen production, thereby achieving certain anti-aging effects.
Blue light operates at wavelengths between 460nm and 480nm, primarily targeting various bacterial colonies within the sebaceous glands. After absorbing blue light, these bacteria are oxidized, leading to the inactivation of Propionibacterium acnes and achieving a certain acne treatment effect.
Performance Testing Standards
According to FDA regulation 878.4810 – Laser surgical instruments for use in general and plastic surgery and dermatology, the beauty device must meet the following testing standards to varying degrees based on its intended use:
Summary
When applying for FDA 510(k) clearance, it is essential to determine the product characteristics and applicable product code. Based on the intended use of the product and laser parameters, select an appropriate predicate device. It is important to ensure that the chosen predicate device has the same intended use, target population, skin type, hair color, wavelength, energy density, pulse duration, output energy, lifespan, and other performance parameters.
If there are differences in performance parameters, a reasonable explanation must be provided to demonstrate that these differences do not raise safety or efficacy concerns. Relevant testing data may be required to support the argument if necessary.