DEVICE CLASS
Class III
REGULATION
21 CFR 886.4275
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES
Recent clearances
P840064Alcon Laboratories · pma2026-02-10
P810031Johnson & Johnson Surgical Vision, Inc. · pma2025-12-16
P000046Anika Therapeutics, Inc. · pma2025-10-15
P890047Alcon Research, Ltd. · pma2025-10-03
P110007Johnson & Johnson Surgical Vision, Inc. · pma2025-01-15
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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