SHASER V-MINI RX

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 Rx.

Pre-market Notification Details

Device IDK132170
510k NumberK132170
Device Name:SHASER V-MINI RX
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant SHASER, INC. 10 MAGUIRE ROAD Lexington,  MA  02421
ContactAnthony Burns
CorrespondentAnthony Burns
SHASER, INC. 10 MAGUIRE ROAD Lexington,  MA  02421
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-15
Decision Date2013-11-26
Summary:summary

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