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Pearl

by Cutera, Inc.

Ref Z12011019

Pearl 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-00816722022141), cleared under FDA 510(k) K063867 on 27 Mar 2007 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722022141), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063867

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816722022141 Basic UDI-DI 00816722022141UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816722022141 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063867 Date27 Mar 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816722022141 registered 12 Oct 2026 Active
  • FDA 510(k) K063867 decided 27 Mar 2007 Active
  • FDA GUDID UDI-DI 00816722022141 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063867
  2. Listed FDA GUDID 00816722022141
  3. Registered EUDAMED B-00816722022141

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Dermatological laser beam guiding handpiece
Model / reference
Z12011019 EUDAMED
Pearl GUDID
Primary DI / UDI-DI
00816722022141
Basic UDI-DI
B-00816722022141
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Dermatological laser beam guiding handpiece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Z12011019
GUDID
Pearl
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 laser beam guiding handpiece

Cleared under the same submission (K063867)

Similar devices in this category

Other devices filed under MULTI–PLATFORM 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 (20, all answered No)