TempSure System

Massager, Vacuum, Radio Frequency Induced Heat

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 IDK200241
510k NumberK200241
Device Name:TempSure System
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant Cynosure LLC 5 Carlisle Road Westford,  MA  01886
ContactKevin O'connell
CorrespondentKevin O'connell
Cynosure LLC 5 Carlisle Road Westford,  MA  01886
Product CodePBX  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-31
Decision Date2020-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494108564 K200241 000
00841494108533 K200241 000
00841494108519 K200241 000
00841494108441 K200241 000
00841494108427 K200241 000
00841494108410 K200241 000
00841494108403 K200241 000

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