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Asset PNMS00161

by Quanta System SpA

Asset PNMS00161 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Quanta System SpA, cleared under FDA 510(k) K103539 on 20 Jan 2011, registered in EUDAMED and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 08033945934231), 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) K103539

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 Number08033945934231 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103539 Date20 Jan 2011DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K103539 decided 20 Jan 2011 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08033945934231 listed 18 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103539
  2. Listed FDA GUDID 08033945934231

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  • Withdrawn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
Asset
Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
PNMS00161
Primary DI / UDI-DI
08033945934231
510(k) Number
FDA product code
GEX
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological frequency-doubled solid-state laser system

Cleared under the same submission (K103539)

Similar devices in this category

Other devices filed under Dermatological frequency-doubled solid-state laser system.

Other devices from Quanta System SpA

See all devices from Quanta System SpA →

Properties

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