FDA product code QER

Camera, Ophthalmic, Slit-Scanning

Ophthalmic·Class 2·21 CFR 886.1120
US regulatory classifications
US Product Code (FDA)
QER
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.1120
View CFR Regulation →
Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Search keywords
About this record

Camera, Ophthalmic, Slit-Scanning 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.