← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
QER — Camera, Ophthalmic, Slit-Scanning
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
DEVICE CLASS
Class II
REGULATION
21 CFR 886.1120
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES
Recent clearances
K243878Carl Zeiss Meditec, Inc. · 510k2025-04-17
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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