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LightLas 577

by Lightmed Corporation

Ref YC0010Model LightLas 577

LightLas 577 (YC0010) is a device classified as Class IIb in the EU and Class II in the US made by Lightmed Corporation, registered in EUDAMED on 24 Apr 2025 (Basic UDI-DI B-04712826770642), cleared under FDA 510(k) K091981 on 28 Sep 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04712826770642), 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) K091981

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-04712826770642 Basic UDI-DI 04712826770642UDI-DIDate24 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04712826770642 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091981 Date28 Sep 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04712826770642 registered 24 Apr 2025 Active
  • FDA 510(k) K091981 decided 28 Sep 2009 Active
  • FDA GUDID UDI-DI 04712826770642 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091981
  2. Listed FDA GUDID 04712826770642
  3. Registered EUDAMED B-04712826770642

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  • Withdrawn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 diode laser system
Device name
LightLas Family of Medical Laser System: Ophthalmic Photocoagulator and Accessories
Model / reference
LightLas 577, YC0010
Primary DI / UDI-DI
04712826770642
Basic UDI-DI
B-04712826770642
510(k) Number
FDA product code
HQF
EMDN code
Z12011099 Laser surgery instruments - other
GMDN term
Ophthalmic diode 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
Poland
GUDID distribution status
In Commercial Distribution
Size
Weight — 20 Kilogram

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 LASER SURGERY INSTRUMENTS - OTHER.

Other devices from Lightmed Corporation

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Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)