← FDA Medical Device Classifications
Camera, Ophthalmic, Slit-Scanning
QER · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1120
Classification
- FDA Product Code
QER- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.1120
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown