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CoolView

by Cutera, Inc. 2 variants

CoolView is a Class II device made by Cutera, Inc., cleared under FDA 510(k) K132185 on 6 Dec 2013, registered in EUDAMED and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00816722022301), active as of 7 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132185

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816722022301 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132185 Date6 Dec 2013DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K132185 decided 6 Dec 2013 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00816722022301 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132185
  2. Listed FDA GUDID 00816722022301

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
CoolView
Primary DI / UDI-DI
00816722022301
510(k) Number
FDA product code
GEX
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological frequency-doubled solid-state laser system

Cleared under the same submission (K132185)

Similar devices in this category

Other devices filed under Dermatological frequency-doubled solid-state laser 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)