TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC

Powered Laser Surgical Instrument

TRIA BEAUTY, INC.

The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Acne Treatment System, Model Ats-1 Otc.

Pre-market Notification Details

Device IDK090312
510k NumberK090312
Device Name:TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
ClassificationPowered Laser Surgical Instrument
Applicant TRIA BEAUTY, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
TRIA BEAUTY, INC. 555 13TH STREET, NW COLUMBIA SQUARE Washington,  DC  20004
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-06
Decision Date2010-01-05
Summary:summary

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