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Opera Evo PDMS00254

by Quanta System SpA

Ref PDMS00254Model Opera EVO

Opera Evo PDMS00254 is a general/multiple surgical diode laser system (EU MDD Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Quanta System SpA, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI B-08059173390700), cleared under FDA 510(k) K202041 on 15 Oct 2020 and listed in FDA GUDID since 28 Nov 2020 (UDI-DI 08059173390700), 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) K202041

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/MDD EUDAMED NumberB-08059173390700 Basic UDI-DI 08059173390700UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059173390700 UDI-DI Date28 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202041 Date15 Oct 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08059173390700 registered 25 Jun 2026 Active
  • FDA 510(k) K202041 decided 15 Oct 2020 Active
  • FDA GUDID UDI-DI 08059173390700 listed 28 Nov 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202041
  2. Listed FDA GUDID 08059173390700
  3. Registered EUDAMED B-08059173390700

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  • Withdrawn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
Opera Evo
Generic name
General/multiple surgical diode laser system
Model / reference
PDMS00254, Opera EVO
Primary DI / UDI-DI
08059173390700
Basic UDI-DI
B-08059173390700
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
GMDN term
General/multiple surgical diode laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
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.

Related devices

Category: General/multiple surgical diode laser system

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from Quanta System SpA

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Properties

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