DEVICE CLASS
Class II
REGULATION
21 CFR 886.1120
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K253176Beyond 700 Pty, Ltd. · 510k2026-06-22
K251353Phelcom Technologies · 510k2026-01-16
K252120Remidio Innovative Solutions Private Limited · 510k2025-12-12
K250770Optina Diagnostics, Inc. · 510k2025-09-04
K243600Forus Health Pvt.Ltd · 510k2025-08-14
K250683Optain Health, Inc. · 510k2025-04-30
K243664Ai Optics · 510k2024-12-17
K242508Verily Life Sciences, LLC · 510k2024-12-09
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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