TempSure System

Electrosurgical, Cutting & Coagulation & Accessories

Cynosure LLC

The following data is part of a premarket notification filed by Cynosure Llc with the FDA for Tempsure System.

Pre-market Notification Details

Device IDK223292
510k NumberK223292
Device Name:TempSure System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Cynosure LLC 5 Carlisle Road Westford,  MA  01886
ContactMichael King
CorrespondentMichael King
Cynosure LLC 5 Carlisle Road Westford,  MA  01886
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-26
Decision Date2022-11-23

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