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 IDK151161
510k NumberK151161
Device Name:VICTUS Femtosecond Laser Platform
ClassificationOphthalmic Femtosecond Laser
Applicant TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR. 1+3 Munich,  DE 80992
ContactFriedrich Moritz
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 Received2015-05-01
Decision Date2015-06-24
Summary:summary

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