Catalys Precision Laser System

Ophthalmic Femtosecond Laser

AMO Manufacturing USA, LLC

The following data is part of a premarket notification filed by Amo Manufacturing Usa, Llc with the FDA for Catalys Precision Laser System.

Pre-market Notification Details

Device IDK172002
510k NumberK172002
Device Name:Catalys Precision Laser System
ClassificationOphthalmic Femtosecond Laser
Applicant AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas,  CA  95035
ContactAnita Xavier
CorrespondentAnita Xavier
AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas,  CA  95035
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2017-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05050474617186 K172002 000
05050474611764 K172002 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.