MeDioStar

Powered Laser Surgical Instrument

ASCLEPION LASER TECHNOLOGIES GMBH

The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Mediostar.

Pre-market Notification Details

Device IDK192483
510k NumberK192483
Device Name:MeDioStar
ClassificationPowered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH Busseler Str. 10 Jena,  DE 07747
ContactAntje Katzer
CorrespondentDania Di Pietro Paolo
ASCLEPION LASER TECHNOLOGIES GMBH Busseler Str. 10 Jena,  DE 07747
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-10
Decision Date2020-03-13

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