FEMTO LDV Z8 Femtosecond Surgical Laser

Ophthalmic Femtosecond Laser

SIE AG, Surgical Instrument Engineering

The following data is part of a premarket notification filed by Sie Ag, Surgical Instrument Engineering with the FDA for Femto Ldv Z8 Femtosecond Surgical Laser.

Pre-market Notification Details

Device IDK213559
510k NumberK213559
Device Name:FEMTO LDV Z8 Femtosecond Surgical Laser
ClassificationOphthalmic Femtosecond Laser
Applicant SIE AG, Surgical Instrument Engineering Allmendstrasse 11 Port,  CH Ch-2502
ContactFrank Ziemer
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeOOE  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-04
Decision Date2022-04-21

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