PJZ — Camera, Ophthalmic, General-Use Class II
FDA product code PJZ covers "Camera, Ophthalmic, General-Use", a Class II medical device regulated under 21 CFR 886.1120. Submissions are reviewed by the Ophthalmic panel.
Classification Details
- Product Code
- PJZ
- Device Class
- Class II
- Regulation Number
- 886.1120
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of diagnostic or aid in diagnosis claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.