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AviClear

by Cutera, Inc.

Ref AVICLEAR

AviClear is a dermatological solid-state laser system (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Cutera, Inc., registered in EUDAMED on 2 Nov 2024 (Basic UDI-DI B-00816722021700) and listed in FDA GUDID since 1 Apr 2022 (UDI-DI 00816722021700), active as of 24 Oct 2026.

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

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-00816722021700 Basic UDI-DI 00816722021700UDI-DIDate2 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722021700 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816722021700 registered 2 Nov 2024 Active
  • FDA GUDID UDI-DI 00816722021700 listed 1 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816722021700
  2. Registered EUDAMED B-00816722021700

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  • Withdrawn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
Dermatological solid-state laser system
Device name
AviClear (Alice)
Model / reference
AVICLEAR
Primary DI / UDI-DI
00816722021700
Basic UDI-DI
B-00816722021700, 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
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
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.

Manufacturer details

EUDAMED SRN
US-MF-000010456
Authorised representative
MDSS GmbH DE-AR-000005430

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)