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Genesis V

by Cutera, Inc.

Genesis V 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 00816722022318), active as of 12 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 12 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 12 Oct 2026.

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816722022318 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 00816722022318 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132185
  2. Listed FDA GUDID 00816722022318

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  • Withdrawn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
Genesis V
Primary DI / UDI-DI
00816722022318
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.

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See all devices from Cutera, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)