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AviClear Large handpiece

by Cutera, Inc.

Ref 7003336, 7003336T

AviClear Large handpiece is a device classified as Class IIb in the EU and Class II in the US made by Cutera, Inc., registered in EUDAMED on 5 Jan 2026 (Basic UDI-DI 00816722021700DH) and listed in FDA GUDID since 18 Aug 2025 (UDI-DI 00816722022714), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00816722021700DH Basic UDI-DI 00816722022714UDI-DIDate5 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722022714 UDI-DI Date18 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00816722021700DH registered 5 Jan 2026 Active
  • FDA GUDID UDI-DI 00816722022714 listed 18 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722022714
  2. Registered EUDAMED 00816722021700DH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AviClear Large handpiece EUDAMED
AviClear GUDID
Generic name
Dermatological solid-state laser system
Model / reference
7003336 EUDAMED
7003336T EUDAMED
AviClear Large handpiece GUDID
Primary DI / UDI-DI
00816722022714
Basic UDI-DI
00816722021700DH
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
Dermatological solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
7003336, 7003336T
GUDID
AviClear Large handpiece
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.

Related devices

Category: Dermatological solid-state laser system

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

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 (22, all answered No)