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Thunder VT PCMS00406

by Quanta System SpA

Thunder VT PCMS00406 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K171711 on 7 Jul 2017, registered in EUDAMED and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 08033945936976), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171711

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08033945936976 UDI-DI Date4 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK171711 Date7 Jul 2017DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K171711 decided 7 Jul 2017 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08033945936976 listed 4 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171711
  2. Listed FDA GUDID 08033945936976

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  • Withdrawn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

Trade name
Thunder VT
Generic name
Dermatological solid-state laser system
Model / reference
PCMS00406
Primary DI / UDI-DI
08033945936976
510(k) Number
FDA product code
GEX
GMDN term
Dermatological solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)