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Fiber Dust

by Quanta System S.p.A.

Ref PFMS00005Model Fiber Dust

Fiber Dust (PFMS00005) is a device classified as Class IIb in the EU and Class II in the US made by Quanta System S.p.A., registered in EUDAMED on 22 Oct 2024 (Basic UDI-DI B-08059173391783), cleared under FDA 510(k) K210142 on 11 Mar 2021 and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 08059173391783), 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) K210142

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-08059173391783 Basic UDI-DI 08059173391783UDI-DIDate22 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08059173391783 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210142 Date11 Mar 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08059173391783 registered 22 Oct 2024 Active
  • FDA 510(k) K210142 decided 11 Mar 2021 Active
  • FDA GUDID UDI-DI 08059173391783 listed 2 Apr 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210142
  2. Listed FDA GUDID 08059173391783
  3. Registered EUDAMED B-08059173391783

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  • Withdrawn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
General/multiple surgical solid-state laser system
Model / reference
Fiber Dust, PFMS00005
Primary DI / UDI-DI
08059173391783
Basic UDI-DI
B-08059173391783
510(k) Number
FDA product code
GEX
EMDN code
Z12011006 Diode–pumped solid–state (dpss) surgical laser
GMDN term
General/multiple surgical solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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
IT-MF-000007393

Similar devices in this category

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

Other devices from Quanta System S.p.A.

See all devices from Quanta System S.p.A. →

Properties

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