← FDA Medical Device Classifications
Microscope, Specular
NQE · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1850
Classification
- FDA Product Code
NQE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.1850
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown