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TruScan Pro

by Lightmed Corporation 11 variants

Ref TP0011Model TruScan Pro

TruScan Pro (TP0011) is a device classified as Class IIb in the EU and Class II in the US made by Lightmed Corporation, registered in EUDAMED on 29 Apr 2025 (Basic UDI-DI B-04712826770871), cleared under FDA 510(k) K190448 on 24 May 2019 and listed in FDA GUDID since 8 Jul 2019 (UDI-DI 04712826770871), 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) K190448

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-04712826770871 Basic UDI-DI 04712826770871UDI-DIDate29 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04712826770871 UDI-DI Date8 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190448 Date24 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04712826770871 registered 29 Apr 2025 Active
  • FDA 510(k) K190448 decided 24 May 2019 Active
  • FDA GUDID UDI-DI 04712826770871 listed 8 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190448
  2. Listed FDA GUDID 04712826770871
  3. Registered EUDAMED B-04712826770871

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  • Withdrawn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

Generic name
Ophthalmic solid-state laser system
Device name
LightLas Pattern Scanning System
Model / reference
TruScan Pro, TP0011
Primary DI / UDI-DI
04712826770871
Basic UDI-DI
B-04712826770871
510(k) Number
FDA product code
HQF
EMDN code
Z12011006, Z12011011, Z12011016
GMDN term
Ophthalmic solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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
TW-MF-000027493
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER.

Other devices from Lightmed Corporation

See all devices from Lightmed Corporation →

Properties

  • Reusable
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)