DEVICE CLASS
Class II
REGULATION
21 CFR 886.4670
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES
Recent clearances
K261264Bausch and Lomb · 510k2026-05-15
K252052Bausch and Lomb, Incorporated · 510k2026-03-25
K250501This AG · 510k2025-11-14
K243395Carl Zeiss Meditec Cataract Technology, Inc. · 510k2025-08-08
K242801Carl Zeiss Meditec Cataract Technology, Inc. · 510k2025-06-11
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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