Sculpsure
K-Number: K171111 · 2017-06-13
ApplicantCynosure, Inc.
Decision Date2017-06-13
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sculpsure is a medical device manufactured by Cynosure, Inc.. It received FDA 510(k) clearance on 2017-06-13 under approval number K171111. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sculpsure?
Sculpsure is a medical device that received FDA 510(k) clearance on 2017-06-13. It is manufactured by Cynosure, Inc.. The 510(k) number is K171111.
When was Sculpsure approved by the FDA?
Sculpsure received FDA 510(k) clearance on 2017-06-13, under approval number K171111.
What company makes Sculpsure?
Sculpsure is manufactured by Cynosure, Inc..
What is the FDA product code for Sculpsure?
The FDA product code for Sculpsure is PKT.
Other Devices by Cynosure, Inc.
Related Devices (Code: PKT)
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.