DEVICE CLASS
Class II
REGULATION
21 CFR 886.5925
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
23
510(K)/PMA CLEARANCES
510k: 23
0
RECALL ENTRIES
Recent clearances
K260507INTEROJO, Inc. · 510k2026-05-29
K253352Pegavision Corporation · 510k2026-05-21
K261299Pegavision Corporation · 510k2026-05-19
K253885GEO MEDICAL CO., LTD. · 510k2026-04-29
K254269St. shine Optical Co., Ltd. · 510k2026-03-19
K252385Pegavision Corporation · 510k2026-03-13
K254052Alcon Laboratories, Inc. · 510k2026-02-13
K251683Bruno Vision Care, LLC · 510k2025-12-23
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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