QUADROSTAR 980

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 Quadrostar 980.

Pre-market Notification Details

Device IDK060459
510k NumberK060459
Device Name:QUADROSTAR 980
ClassificationPowered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena,  DE 07745
ContactReinhard Thieme
CorrespondentReinhard Thieme
ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena,  DE 07745
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-22
Decision Date2006-03-20
Summary:summary

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