TempSure
K-Number: K190678 · 2019-07-24
ApplicantCynosure, Inc.
Decision Date2019-07-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TempSure is a medical device manufactured by Cynosure, Inc.. It received FDA 510(k) clearance on 2019-07-24 under approval number K190678. 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?
TempSure is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Cynosure, Inc.. The 510(k) number is K190678.
When was TempSure approved by the FDA?
TempSure received FDA 510(k) clearance on 2019-07-24, under approval number K190678.
What company makes TempSure?
TempSure is manufactured by Cynosure, Inc..
What is the FDA product code for TempSure?
The FDA product code for TempSure 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.