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OOE — Ophthalmic Femtosecond Laser Class II

FDA Device Classification

Classification Details

Product Code
OOE
Device Class
Class II
Regulation Number
886.4390
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252682alcon laboratoriesLenSx Laser System (8065000944)September 24, 2025
K243896alcon laboratoriesLenSx Laser System (8065998162)April 28, 2025
K223566johnson and johnson surgical visionELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceApril 14, 2023
K223838amo manufacturing usaCatalys™ Precision Laser SystemApril 12, 2023
K220259lensarALLY Adaptive Cataract Treatment SystemJune 9, 2022
K220516amo manufacturing usaCATALYS Precision Laser systemMay 17, 2022
K213559sie ag,surgical instrument engineeringFEMTO LDV Z8 Femtosecond Surgical LaserApril 21, 2022
K210701amo manufacturing usaCATALYS Precision Laser SystemApril 7, 2021
K200724technolas perfect visionVICTUS Femtosecond Laser PlatformSeptember 1, 2020
K200056amo manufacturng usaCatalys Precision Laser SystemMay 18, 2020
K182795lensarLENSAR Laser System - fs 3D (LLS-fs 3D)December 21, 2018
K182083amo manufacturing usaCatalys Precision Laser SystemNovember 9, 2018
K181430lensarLENSAR Laser System - fs 3D (LLS-fs 3D)August 9, 2018
K173660alcon laboratoriesLenSx Laser SystemMarch 27, 2018
K173346lensarLENSAR Laser System - fs 3D (LLS-fs 3D)March 2, 2018
K171014technolas perfect visionVICTUS Femtosecond Laser PlatformOctober 19, 2017
K172002amo manufacturing usaCatalys Precision Laser SystemAugust 25, 2017
K171337lensarLENSAR Laser System – fs 3D (LLS-fs 3D)August 10, 2017
K170322abbott medical opticsCatalys Precision Laser SystemMay 19, 2017
K170576lensarLENSAR Laser System - fs 3D (LLS-fs 3D)May 5, 2017