QER — Camera, Ophthalmic, Slit-Scanning Class II
FDA product code QER covers "Camera, Ophthalmic, Slit-Scanning", a Class II medical device regulated under 21 CFR 886.1120. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QER
- Device Class
- Class II
- Regulation Number
- 886.1120
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.