Dynamis Pro 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 Dynamis Pro Family.

Pre-market Notification Details

Device IDK213267
510k NumberK213267
Device Name:Dynamis Pro Family
ClassificationPowered Laser Surgical Instrument
Applicant Fotona D.o.o. Stegne 7 Ljubljana,  SI 1000
ContactMarko Berdajs
CorrespondentMarko Berdajs
Fotona D.o.o. Stegne 7 Ljubljana,  SI 1000
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-09-08

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