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Bare Fiber, single-use, sterile

by CeramOptec GmbH 7 variants

Part of a family of 89 devices: see the family page

Ref 503200120

Bare Fiber, single-use, sterile (503200120) is a device classified as Class IIa in the EU and Class II in the US made by CeramOptec GmbH, registered in EUDAMED on 1 Dec 2025 (Basic UDI-DI 404905902N2), cleared under FDA 510(k) K250504 on 14 Jul 2025 and listed in FDA GUDID since 25 Sep 2025 (UDI-DI 04049059519336), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250504

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404905902N2 Basic UDI-DI 04049059519336UDI-DIDate1 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04049059519336 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK250504 Date14 Jul 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 404905902N2 registered 1 Dec 2025 Active
  • FDA 510(k) K250504 decided 14 Jul 2025 Active
  • FDA GUDID UDI-DI 04049059519336 listed 25 Sep 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250504
  2. Listed FDA GUDID 04049059519336
  3. Registered EUDAMED 404905902N2

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  • Withdrawn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
CeramOptec
Generic name
General/multiple surgical solid-state laser system
Device name
Bare Fiber, single-use, sterile
Model / Ref / Catalog
503200120, Leonardo® Duster ScopeSafe Fiber 550um, IC
Primary DI / UDI-DI
04049059519336
Basic UDI-DI
404905902N2
510(k) Number
FDA product code
GEX
EMDN code
Z12011085 Laser surgery instruments - consumables
GMDN term
General/multiple surgical solid-state laser system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
503200120
GUDID
Leonardo® Duster ScopeSafe Fiber 550um, IC
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 04049059519336: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa 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
DE-MF-000005607

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Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)