OOEClass II

Ophthalmic Femtosecond Laser

21 CFR 886.4390 / Ophthalmic

OOE is the FDA product code for Ophthalmic Femtosecond Laser, a class II device type, regulated under 21 CFR 886.4390. FDA's definition for this code reads: "Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery". As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2025-09-24, and 8 recalls.

Classification record

Product code: OOE
Device name: Ophthalmic Femtosecond Laser
FDA definition: Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Regulation: 21 CFR 886.4390
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 47
Ingested recalls: 8

Clearances, product code OOE

By decision year

47 clearances under product code OOE with a decision year between 2009 and 2025, 2017 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code OOE by decision year
Year	Clearances
2009	2
2010	3
2011	4
2012	4
2013	2
2014	4
2015	5
2016	2
2017	6
2018	5
2020	2
2021	1
2022	3
2023	2
2025	2

Applicants with the most clearances

Product code OOE

Applicants holding the most 510(k) clearances under product code OOE
Applicant	Clearances
LENSAR, Inc	13
Technolas Perfect Vision GmbH	9
Advanced Medical Optics, Inc.	7
Alcon Laboratories	6
Lensx Lasers, Inc.	4
OptiMedica Corp.	4
Sie Ag,Surgical Instrument Engineering	2
Alcon Lensx, Inc.	1
Amo Manufacturng USA, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order