FDA product code NQE
Microscope, Specular
Ophthalmic·Class 2·21 CFR 886.1850
US regulatory classifications
- US Product Code (FDA)
- NQEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 886.1850View CFR Regulation →
- Medical specialty
- Ophthalmic
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
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About this record
Microscope, Specular is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.