QZP — Camera, Ophthalmic, Non-Prescription Class II
FDA product code QZP covers "Camera, Ophthalmic, Non-Prescription", a Class II medical device regulated under 21 CFR 886.1120. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- QZP
- Device Class
- Class II
- Regulation Number
- 886.1120
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.