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Photic Stimulator

by Lifelines Ltd. 2 variants

Ref 1290AModel Photic

Photic Stimulator (1290A) 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 05060275450707), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101691↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506027545PH1E2 Basic UDI-DI 05060275450707UDI-DIDate2 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060275450707 UDI-DI Date4 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) 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 05060275450707 listed 4 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101691
  2. Listed FDA GUDID 05060275450707
  3. Registered EUDAMED 506027545PH1E2

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Photic Stimulator EUDAMED
Lifelines Photic Stimulator GUDID
Generic name
Visual stimulator
Device name
Photic
Model / reference
Photic EUDAMED
1290A EUDAMED
Photic Stimulator Kit GUDID
Primary DI / UDI-DI
05060275450707
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
1290A
GUDID
Photic Stimulator Kit
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

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS.

Other devices from Lifelines Ltd.

See all devices from Lifelines Ltd. →

Properties

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