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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-10
Decision Date2020-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04058784000279 K192483 000

Trademark Results [MeDioStar]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDIOSTAR
MEDIOSTAR
76200554 2655739 Live/Registered
ASCLEPION LASER TECHNOLOGIES GMBH
2001-01-26

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