TATTOOSTAR FAMILY

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 Tattoostar Family.

Pre-market Notification Details

Device IDK060787
510k NumberK060787
Device Name:TATTOOSTAR FAMILY
ClassificationPowered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH 1A; IM SEMMICHT Jena,  DE 07751
ContactReinhard Thieme
CorrespondentReinhard Thieme
ASCLEPION LASER TECHNOLOGIES GMBH 1A; IM SEMMICHT Jena,  DE 07751
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-23
Decision Date2006-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04058784000132 K060787 000
04058784000125 K060787 000

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