UltraShape System
K-Number: K161952 · 2016-11-07
ApplicantSyneron Medical, Ltd.
Decision Date2016-11-07
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UltraShape System is a medical device manufactured by Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2016-11-07 under approval number K161952. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltraShape System?
UltraShape System is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by Syneron Medical, Ltd.. The 510(k) number is K161952.
When was UltraShape System approved by the FDA?
UltraShape System received FDA 510(k) clearance on 2016-11-07, under approval number K161952.
What company makes UltraShape System?
UltraShape System is manufactured by Syneron Medical, Ltd..
What is the FDA product code for UltraShape System?
The FDA product code for UltraShape System is OHV.
Other Devices by Syneron Medical, Ltd.
Related Devices (Code: OHV)
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.