Product code QZP
- Device name
- Camera, Ophthalmic, Non-Prescription
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1120
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset