Can I read FDA Approval for Biophotas Celluma3 Device on EtoBox?

FDA Approval for Biophotas Celluma3 Device by Eve Aoki is a document available to read on EtoBox.

What is FDA Approval for Biophotas Celluma3 Device about?

The FDA has determined that the Biophotas Celluma3 device is substantially equivalent to legally marketed predicate devices for the treatment of full face wrinkles. The device utilizes LED technology to emit visible and infrared light, intended for both cosmetic and therapeutic applications. It is classified as a Class II device under regulation 21 CFR 878.4810 and may be marketed subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act.

Author

Eve Aoki

Language

EN