Tria Sapphire

Over-the-counter Powered Light Based Laser For Acne

TRIA BEAUTY, INC.

The following data is part of a premarket notification filed by Tria Beauty, Inc. with the FDA for Tria Sapphire.

Pre-market Notification Details

Device IDK160821
510k NumberK160821
Device Name:Tria Sapphire
ClassificationOver-the-counter Powered Light Based Laser For Acne
Applicant TRIA BEAUTY, INC. 4160 Dublin Blvd., Ste 200 Dublin,  CA  94568
ContactHeather Tanner
CorrespondentJonathan Kahan
HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington,  DC  20004
Product CodeOLP  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-24
Decision Date2016-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B5863374 K160821 000
B5863386 K160821 000

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