FDA.reportPublic FDA data

510(k) K220516

Device
CATALYS Precision Laser system
Applicant
Amo Manufacturing USA, LLC
510(k) number
K220516
Product code
OOE
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-17
Date received
2022-02-23
Regulation
886.4390
Classification name
Ophthalmic Femtosecond Laser
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alex Etlin
Address
510 Cottonwood Dr. Milpitas CA US 95035 95035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OOE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.2025-09-24
K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.2025-04-28
K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.2023-04-14
K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC2023-04-12
K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.2022-06-09
K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering2022-04-21
K210701CATALYS Precision Laser SystemAmo Manufacturing USA, LLC2021-04-07
K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH2020-09-01
K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC2020-05-18
K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.2018-12-21
K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC2018-11-09
K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.2018-08-09
K173660LenSx Laser SystemAlcon Laboratories, Inc.2018-03-27
K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.2018-03-02
K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH2017-10-19