REA — High-Power Laser Light Show Projector Class N
FDA product code REA covers "High-Power Laser Light Show Projector", a Class N medical device.
Classification Details
- Product Code
- REA
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- Medical Specialty
- Unknown
- Implant
- No
Definition
Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.