REK — Research Laser Class N
FDA product code REK covers "Research Laser", a Class N medical device.
Classification Details
- Product Code
- REK
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- Medical Specialty
- Unknown
- Implant
- No
Definition
Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research.