LightWalker Laser System Family

Powered Laser Surgical Instrument

Fotona D.o.o.

The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Lightwalker Laser System Family.

Pre-market Notification Details

Device IDK202985
510k NumberK202985
Device Name:LightWalker Laser System Family
ClassificationPowered Laser Surgical Instrument
Applicant Fotona D.o.o. Stegne 7 Ljubljana,  SI Si-1000
ContactPucer Anja
CorrespondentPucer Anja
Fotona D.o.o. Stegne 7 Ljubljana,  SI Si-1000
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-03-19

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