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truSculpt 3D

by Cutera, Inc.

truSculpt 3D is a Class II device made by Cutera, Inc., listed in FDA GUDID since 27 Mar 2017 (UDI-DI 00816722022431), registry data as of 21 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816722022431 UDI-DI Date27 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Radio-frequency skin/body contouring system
Model / reference
truSculpt 3D
Primary DI / UDI-DI
00816722022431
FDA product code
GEX, PBX
GMDN term
Radio-frequency skin/body contouring system
Device class
Class II
Regulation number
878.4810, 878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radio-frequency skin/body contouring system

Similar devices in this category

Other devices filed under Radio-frequency skin/body contouring system.

Other devices from Cutera, Inc.

  • truSculpt iD

    Class II

  • Titan V

    Class II

  • CoolView

    Class II

  • AviClear

    Class II

See all devices from Cutera, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)