SHASER V-MINI 2 HAIR REMOVAL SYSTEM

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

SHASER, INC.

The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser V-mini 2 Hair Removal System.

Pre-market Notification Details

Device IDK133201
510k NumberK133201
Device Name:SHASER V-MINI 2 HAIR REMOVAL SYSTEM
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
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 CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10074590542926 K133201 000
10074590546030 K133201 000
10074590535478 K133201 000

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