Ophthalmic Femtosecond Laser

Product Code: OOE

Ophthalmic Medical Laser Products

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

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 886.4390


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OOE

4399Ophthalmic Femtosecond LaserOphthalmic Laser.

Total Product Life Cycle (TPLC) Devices

4399Ophthalmic Femtosecond LaserOphthalmic Laser.

Pre-market Notifications for OOE

K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.
K213559FEMTO LDV Z8 Femtosecond Surgical LaserSIE AG, Surgical Instrument Engineering
K210701CATALYS Precision Laser SystemAMO Manufacturing USA, LLC
K200056Catalys Precision Laser SystemAMO Manufacturng USA, LLC
K182795LENSAR Laser System - Fs 3D (LLS-fs 3D)Lensar, Inc.
K182083Catalys Precision Laser SystemAMO Manufacturing USA, LLC
K181430LENSAR Laser System - Fs 3D (LLS-fs 3D)LENSAR, Inc.
K173660LenSx Laser SystemAlcon Laboratories, Inc.
K173346LENSAR Laser System - Fs 3D (LLS-fs 3D)Lensar, Inc.
K172002Catalys Precision Laser SystemAMO Manufacturing USA, LLC
K171337LENSAR Laser System – Fs 3D (LLS-fs 3D)LENSAR, Inc.
K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH
K170576LENSAR Laser System - Fs 3D (LLS-fs 3D)LENSAR, Inc.
K170322Catalys Precision Laser SystemAbbott Medical Optics Inc.
K163551LenSx Laser SystemAlcon Laboratories, Inc.

Global Unique Device Identification Database

00380659981623Ophthalmic femtosecond laser
00380659909412Ophthalmic femtosecond laser
10380659908191Ophthalmic femtosecond laser
07640167751167Ophthalmic Femtosecond Laser
07640167751105Ophthalmic Femtosecond Laser
07640167751129Ophthalmic Femtosecond Laser
07640167751143Ophthalmic Femtosecond Laser
07640167751082Ophthalmic Femtosecond Laser
07640167751068Ophthalmic Femtosecond Laser
07640167751051Ophthalmic Femtosecond Laser
07640167750016Ophthalmic Femtosecond Laser
05050474651487Ophthalmic femtosecond laser
05050474617186Ophthalmic femtosecond laser
05050474609792Ophthalmic femtosecond laser
05050474609778Ophthalmic femtosecond laser

Maude Adverse Events

LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-31
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-31
LENSX LASER SYSTEMALCON LENSX, INC.2020-03-30
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-27
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-27
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-27
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-25
LIQUID OPTICS INTERFACEJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-19
LENSX LASER SYSTEMALCON LENSX, INC.2020-03-17
LENSX LASER SYSTEMALCON LENSX, INC.2020-03-17
ZIEMER FEMTO LDVSIE AG, SURGICAL INSTRUMENT ENGINEERING2020-03-10
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-10
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-06
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-06
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-06
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-05
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-02
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-02
LENSAR LASER SYSTEM-FS 3DLENSAR, INC2020-02-28
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-28
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-28
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-24
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-24
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-24
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-24
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-21
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-21
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-21
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-20
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-13
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-13
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-13
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-12
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-11
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-02-06
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-05
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-05
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-02-05
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-03
LENSX LASER SYSTEMALCON LENSX, INC.2020-02-03
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-01-28
CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-01-28
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-28
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-28
LENSX LASER SYSTEMALCON LENSX, INC.2020-01-28
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-27
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-27
LENSX LASER SYSTEMALCON LENSX, INC.2020-01-23
LENSX LASER SYSTEMALCON LENSX, INC.2020-01-21
LENSX LASER SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-01-20

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