truSculpt RF Device; truSculpt; truSculpt 3D
K-Number: K180709 · 2018-06-06
ApplicantCutera, Inc.
Decision Date2018-06-06
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
truSculpt RF Device; truSculpt; truSculpt 3D is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2018-06-06 under approval number K180709. 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 truSculpt RF Device; truSculpt; truSculpt 3D?
truSculpt RF Device; truSculpt; truSculpt 3D is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Cutera, Inc.. The 510(k) number is K180709.
When was truSculpt RF Device; truSculpt; truSculpt 3D approved by the FDA?
truSculpt RF Device; truSculpt; truSculpt 3D received FDA 510(k) clearance on 2018-06-06, under approval number K180709.
What company makes truSculpt RF Device; truSculpt; truSculpt 3D?
truSculpt RF Device; truSculpt; truSculpt 3D is manufactured by Cutera, Inc..
What is the FDA product code for truSculpt RF Device; truSculpt; truSculpt 3D?
The FDA product code for truSculpt RF Device; truSculpt; truSculpt 3D is PBX.
Other Devices by Cutera, Inc.
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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.