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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2018-06-06 under 510(k) 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. The listed applicant is Cutera, Inc.. The 510(k) number is K180709.

When did truSculpt RF Device; truSculpt; truSculpt 3D receive FDA 510(k) clearance?

truSculpt RF Device; truSculpt; truSculpt 3D received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180709.

Who is the listed applicant for truSculpt RF Device; truSculpt; truSculpt 3D?

The FDA 510(k) record lists Cutera, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Cutera, Inc. as applicant

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Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

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