FDA 510(k)

truSculpt

K-Number: K162512 · 2016-12-09

Decision Date2016-12-09

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

truSculpt is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162512. 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?

truSculpt is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Cutera, Inc.. The 510(k) number is K162512.

When did truSculpt receive FDA 510(k) clearance?

truSculpt received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162512.

Who is the listed applicant for truSculpt?

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?

The FDA product code for truSculpt is PBX.

Other records listing Cutera, Inc. as applicant

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.

K251149AviClear Laser System K233237xeo+ Family K230660AviClear Laser System K223110truSculpt iD K221407truSculpt iD K213461AviClear Laser System

View all 14 devices →

Related Devices (Code: PBX)

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.