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truSculpt

by Cutera, Inc.

Ref TRUSCULPT

truSculpt is a device classified as Class IIb in the EU and Class II in the US made by Cutera, Inc., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-00816722021403) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722021403), active (EUDAMED), not in commercial distribution (GUDID) as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816722021403 Basic UDI-DI 00816722021403UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722021403 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722021403 registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 00816722021403 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722021403
  2. Registered EUDAMED B-00816722021403

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Radio-frequency skin/body contouring system
Model / reference
truSculpt
Primary DI / UDI-DI
00816722021403
Basic UDI-DI
B-00816722021403
FDA product code
PBX, NUV, ISA
EMDN code
Z12010999 Electrosurgery instruments - other
GMDN term
Radio-frequency skin/body contouring system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400, 878.4810, 890.5660
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - OTHER.

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 (20, all answered No)