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 IDK210701
510k NumberK210701
Device Name:CATALYS Precision Laser System
ClassificationOphthalmic Femtosecond Laser
Applicant AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas,  CA  95035
ContactLaarni Ricafort
CorrespondentLaarni Ricafort
AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas,  CA  95035
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-09
Decision Date2021-04-07

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