VICTUS FEMTOSECOND LASER PLATFORM

Ophthalmic Femtosecond Laser

TECHNOLAS PERFECT VISION GMBH

The following data is part of a premarket notification filed by Technolas Perfect Vision Gmbh with the FDA for Victus Femtosecond Laser Platform.

Pre-market Notification Details

Device IDK132534
510k NumberK132534
Device Name:VICTUS FEMTOSECOND LASER PLATFORM
ClassificationOphthalmic Femtosecond Laser
Applicant TECHNOLAS PERFECT VISION GMBH 1025 SANCHEZ STREET San Francisco,  CA  94114
ContactKen Nehmer
CorrespondentKen Nehmer
TECHNOLAS PERFECT VISION GMBH 1025 SANCHEZ STREET San Francisco,  CA  94114
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-13
Decision Date2014-02-14
Summary:summary

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