InMode System MiniFX Handpiece
K-Number: K160329 · 2016-08-19
ApplicantInmode MD , Ltd.
Decision Date2016-08-19
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
InMode System MiniFX Handpiece is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-08-19 under approval number K160329. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InMode System MiniFX Handpiece?
InMode System MiniFX Handpiece is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K160329.
When was InMode System MiniFX Handpiece approved by the FDA?
InMode System MiniFX Handpiece received FDA 510(k) clearance on 2016-08-19, under approval number K160329.
What company makes InMode System MiniFX Handpiece?
InMode System MiniFX Handpiece is manufactured by Inmode MD , Ltd..
What is the FDA product code for InMode System MiniFX Handpiece?
The FDA product code for InMode System MiniFX Handpiece is PBX.
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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.