OPTIMEDICA 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 Optimedica Catalys Precision Laser System.

Pre-market Notification Details

Device IDK113479
510k NumberK113479
Device Name:OPTIMEDICA CATALYS PRECISION LASER SYSTEM
ClassificationOphthalmic Femtosecond Laser
Applicant OPTIMEDICA CORPORATION 3100 CORONADO DRIVE Santa Clara,  CA  95054
ContactAlan Marquardt
CorrespondentAlan Marquardt
OPTIMEDICA CORPORATION 3100 CORONADO DRIVE Santa Clara,  CA  95054
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-23
Decision Date2011-12-21
Summary:summary

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