OOE

Ophthalmic Femtosecond Laser

Product code

OOE

Device name

Ophthalmic Femtosecond Laser

Device class

Class 2

21 CFR

21 CFR 886.4390

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

47 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-24.

2 summaries are archived here for direct download.