DERMABLATE EFFECT

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 Dermablate Effect.

Pre-market Notification Details

Device IDK081541
510k NumberK081541
Device Name:DERMABLATE EFFECT
ClassificationPowered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena,  DE 07747
ContactAntje Katzer
CorrespondentAntje Katzer
ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena,  DE 07747
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-02
Decision Date2009-02-23
Summary:summary

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