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Photic Stimulator

by Lifelines Ltd. 2 variants

Ref 1290Model Photic

Photic Stimulator (1290) is a device classified as Class I in the EU and Class II in the US made by Lifelines Ltd., registered in EUDAMED on 2 Oct 2025 (Basic UDI-DI 506027545PH1E2), cleared under FDA 510(k) K101691 on 10 Aug 2010 and listed in FDA GUDID since 4 Jul 2019 (UDI-DI 05060275450165), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101691

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/MDR EUDAMED Number506027545PH1E2 Basic UDI-DI 05060275450165UDI-DIDate2 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450165 UDI-DI Date4 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK101691 Date10 Aug 2010IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506027545PH1E2 registered 2 Oct 2025 Active
  • FDA 510(k) K101691 decided 10 Aug 2010 Active
  • FDA GUDID UDI-DI 05060275450165 listed 4 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101691
  2. Listed FDA GUDID 05060275450165
  3. Registered EUDAMED 506027545PH1E2

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  • Withdrawn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

Trade name
Photic Stimulator EUDAMED
Lifelines Photic Stimulator GUDID
Generic name
Visual stimulator
Device name
Photic
Model / Ref / Catalog
Photic, 1290, Photic Stimulator
Primary DI / UDI-DI
05060275450165
Basic UDI-DI
506027545PH1E2
510(k) Number
FDA product code
GWE
EMDN code
Z129005 Generic photostimulators
GMDN term
Visual stimulator
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1890
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Photic
1290
GUDID
Photic Stimulator
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
GB-MF-000020001
Authorised representative
Incereb Ltd IE-AR-000002462

Similar devices in this category

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Other devices from Lifelines Ltd.

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)