Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family

Powered Laser Surgical Instrument

SHASER, INC.

The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Skin Beauty Skinrejuv Intense, Pulsed Light System Family.

Pre-market Notification Details

Device IDK142924
510k NumberK142924
Device Name:Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
ClassificationPowered Laser Surgical Instrument
Applicant SHASER, INC. 10 MAGUIRE RD BUILDING ONE Lexington,  MA  02421
ContactAnthony Burns
CorrespondentAnthony Burns
SHASER, INC. 10 MAGUIRE RD BUILDING ONE Lexington,  MA  02421
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-08
Decision Date2015-02-13
Summary:summary

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