OOE · Class II · 21 CFR 886.4390

FDA Product Code OOE: Ophthalmic Femtosecond Laser

Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.

Leading manufacturers include Lensar, Inc., Amo Manufacturing USA, LLC and Alcon Laboratories, Inc..

47
Total
47
Cleared
133d
Avg days
2009
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 81d recently vs 136d historically

FDA 510(k) Cleared Ophthalmic Femtosecond Laser Devices (Product Code OOE)

47 devices
1–24 of 47
Cleared Sep 24, 2025
LenSx Laser System (8065000944)
K252682
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Apr 28, 2025
LenSx Laser System (8065998162)
K243896
Alcon Laboratories, Inc.
Ophthalmic · 131d
Cleared Apr 14, 2023
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
K223566
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 136d
Cleared Apr 12, 2023
Catalys™ Precision Laser System
K223838
Amo Manufacturing USA, LLC
Ophthalmic · 111d
Cleared Jun 09, 2022
ALLY Adaptive Cataract Treatment System
K220259
Lensar, Inc.
Ophthalmic · 129d
Cleared May 17, 2022
CATALYS Precision Laser system
K220516
Amo Manufacturing USA, LLC
Ophthalmic · 83d
Cleared Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 168d
Cleared Apr 07, 2021
CATALYS Precision Laser System
K210701
Amo Manufacturing USA, LLC
Ophthalmic · 29d
Cleared Sep 01, 2020
VICTUS Femtosecond Laser Platform
K200724
Technolas Perfect Vision GmbH
Ophthalmic · 166d
Cleared May 18, 2020
Catalys Precision Laser System
K200056
Amo Manufacturng USA, LLC
Ophthalmic · 126d
Cleared Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795
Lensar, Inc.
Ophthalmic · 81d
Cleared Nov 09, 2018
Catalys Precision Laser System
K182083
Amo Manufacturing USA, LLC
Ophthalmic · 99d
Cleared Aug 09, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430
Lensar, Inc.
Ophthalmic · 69d
Cleared Mar 27, 2018
LenSx Laser System
K173660
Alcon Laboratories, Inc.
Ophthalmic · 118d
Cleared Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346
Lensar, Inc.
Ophthalmic · 128d

About Product Code OOE - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code OOE since 2009, with 47 receiving FDA clearance (average review time: 133 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - OOE Product Code

Recent submissions under OOE have taken an average of 81 days to reach a decision - down from 136 days historically, suggesting improved FDA processing for this classification.

OOE devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →