TempSure System
K-Number: K182365 · 2018-10-24
ApplicantCynosure, Inc.
Decision Date2018-10-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TempSure System is a medical device manufactured by Cynosure, Inc.. It received FDA 510(k) clearance on 2018-10-24 under approval number K182365. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TempSure System?
TempSure System is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Cynosure, Inc.. The 510(k) number is K182365.
When was TempSure System approved by the FDA?
TempSure System received FDA 510(k) clearance on 2018-10-24, under approval number K182365.
What company makes TempSure System?
TempSure System is manufactured by Cynosure, Inc..
What is the FDA product code for TempSure System?
The FDA product code for TempSure System is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.