Catalys Precision Laser System

Ophthalmic Femtosecond Laser

Optimedica Corporation

The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Catalys Precision Laser System.

Pre-market Notification Details

Device IDK161455
510k NumberK161455
Device Name:Catalys Precision Laser System
ClassificationOphthalmic Femtosecond Laser
Applicant Optimedica Corporation 1310 Moffet Park Drive Sunnyvale,  CA  94089
ContactAnkur Kaushal
CorrespondentAnkur Kaushal
Optimedica Corporation 1310 Moffet Park Drive Sunnyvale,  CA  94089
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-26
Decision Date2016-09-20
Summary:summary

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