FDA product code QZP

Camera, Ophthalmic, Non-Prescription

Ophthalmic·Class 2·21 CFR 886.1120
US regulatory classifications
US Product Code (FDA)
QZP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.1120
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.

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About this record

Camera, Ophthalmic, Non-Prescription 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.