Amo Manufacturing USA, LLC - FDA 510(k) Cleared Devices
Recent clearances: Catalys™ Precision Laser System, CATALYS Precision Laser system, CATALYS Precision Laser System
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amo Manufacturing USA, LLC Ophthalmic ✕
5 devices
Cleared
Apr 12, 2023
Catalys™ Precision Laser System
Ophthalmic
111d
Cleared
May 17, 2022
CATALYS Precision Laser system
Ophthalmic
83d
Cleared
Apr 07, 2021
CATALYS Precision Laser System
Ophthalmic
29d
Cleared
Nov 09, 2018
Catalys Precision Laser System
Ophthalmic
99d
Cleared
Aug 25, 2017
Catalys Precision Laser System
Ophthalmic
53d