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Shiny

by Ids Ltd.

Ref IDS-UM-0722Model SHINY

Shiny (IDS-UM-0722) is an intense pulsed light skin surface treatment system (EU MDD Class IIb; FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Ids Ltd., registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI B-08809578390030), cleared under FDA 510(k) K181868 on 5 Oct 2018 and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 08809578390030), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809578390030 Basic UDI-DI 08809578390030UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809578390030 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181868 Date5 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809578390030 registered 28 Apr 2026 Active
  • FDA 510(k) K181868 decided 5 Oct 2018 Active
  • FDA GUDID UDI-DI 08809578390030 listed 31 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181868
  2. Listed FDA GUDID 08809578390030
  3. Registered EUDAMED B-08809578390030

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  • Withdrawn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
Shiny EUDAMED
Phototherapy Unit GUDID
Generic name
Intense pulsed light skin surface treatment system
Model / reference
SHINY EUDAMED
IDS-UM-0722 EUDAMED
SHINY RPL SYSTEM GUDID
Primary DI / UDI-DI
08809578390030
Basic UDI-DI
B-08809578390030
510(k) Number
FDA product code
ONF
EMDN code
Z12040202 Phototherapy equipment
GMDN term
Intense pulsed light skin surface treatment system
Device class
Class IIb 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
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SHINY
IDS-UM-0722
GUDID
SHINY RPL SYSTEM
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
KR-MF-000018259
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Red-light phototherapy unit, professional

Similar devices in this category

Other devices filed under PHOTOTHERAPY EQUIPMENT.

Other devices from Ids Ltd.

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Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)