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FDA PRODUCT CODE · CLASS II

OOE — Ophthalmic Femtosecond Laser

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

DEVICE CLASS
Class II
REGULATION
21 CFR 886.4390
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K252682Alcon Laboratories, Inc. · 510k2025-09-24
K243896Alcon Laboratories, Inc. · 510k2025-04-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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