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FDA 510(k)

truSculpt

K-Number: K162512 · 2016-12-09

ApplicantCutera, Inc.
Decision Date2016-12-09
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

truSculpt is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval 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. It is manufactured by Cutera, Inc.. The 510(k) number is K162512.

When was truSculpt approved by the FDA?

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

What company makes truSculpt?

truSculpt is manufactured by Cutera, Inc..

What is the FDA product code for truSculpt?

The FDA product code for truSculpt is PBX.

Other Devices by Cutera, Inc.

K160488Cutera enlighten III Laser System K153671Family of CoolGlide Aesthetic Lasers K172077Cutera enlighten III Laser System K172004truSculpt K170936Cutera enlighten III Laser System K182997enlighten III Laser System

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Related Devices (Code: PBX)

K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd. K153568InMode Plus SystemInmode MD , 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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