Skip to content

Extra

by Active Optical Systems Ltd

Ref 618Model 518

Extra (618) is a multi-modality skin surface treatment system (EU MDD Class IIa; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Active Optical Systems Ltd, registered in EUDAMED on 27 Jun 2022 (Basic UDI-DI B-07290016727067), cleared under FDA 510(k) K050950 on 29 Apr 2005 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 07290016727067), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050950

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016727067 Basic UDI-DI 07290016727067UDI-DIDate27 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016727067 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK050950 Date29 Apr 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016727067 registered 27 Jun 2022 Active
  • FDA 510(k) K050950 decided 29 Apr 2005 Active
  • FDA GUDID UDI-DI 07290016727067 listed 11 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K050950
  2. Listed FDA GUDID 07290016727067
  3. Registered EUDAMED B-07290016727067

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  • Withdrawn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

Trade name
Extra EUDAMED
Optima GUDID
Generic name
Multi-modality skin surface treatment system
Model / reference
518, 618
Primary DI / UDI-DI
07290016727067
Basic UDI-DI
B-07290016727067
510(k) Number
FDA product code
GEX
EMDN code
Z12040202 Phototherapy equipment
GMDN term
Multi-modality skin surface treatment system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
IL-MF-000024754
Authorised representative
QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665

Related devices

Category: Red-light phototherapy unit, professional

Similar devices in this category

Other devices filed under PHOTOTHERAPY EQUIPMENT.

Other devices from Active Optical Systems Ltd

  • Spirit 916

    Class II

  • Crystal 512

    Class II

  • Top Epil Classic 1

    Class I

  • Sheerwave 360

    Class II

See all devices from Active Optical Systems Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)