SHASER IPL 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 Ipl Hair Removal System.

Pre-market Notification Details

Device IDK103560
510k NumberK103560
Device Name:SHASER IPL HAIR REMOVAL SYSTEM
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant SHASER, INC. 32 HARRISON ST. Melrose,  MA  02176
ContactGlen Emelock
CorrespondentGlen Emelock
SHASER, INC. 32 HARRISON ST. Melrose,  MA  02176
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-03
Decision Date2011-05-18
Summary:summary

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