SlimShape System
K-Number: K163415 · 2017-04-20
ApplicantSyneron Medical, Ltd.
Decision Date2017-04-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SlimShape System is a medical device manufactured by Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2017-04-20 under approval number K163415. 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 SlimShape System?
SlimShape System is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Syneron Medical, Ltd.. The 510(k) number is K163415.
When was SlimShape System approved by the FDA?
SlimShape System received FDA 510(k) clearance on 2017-04-20, under approval number K163415.
What company makes SlimShape System?
SlimShape System is manufactured by Syneron Medical, Ltd..
What is the FDA product code for SlimShape System?
The FDA product code for SlimShape 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.