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OptiScan OAM001857

by Quanta System SpA

Ref OAM001857Model OptiScan

OptiScan OAM001857 is a device classified as Class IIb in the EU and Class II in the US made by Quanta System SpA, registered in EUDAMED on 17 Jul 2026 (Basic UDI-DI B-08033945938833), cleared under FDA 510(k) K172198 on 17 Oct 2017 and listed in FDA GUDID since 8 Jun 2018 (UDI-DI 08033945938833), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172198

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033945938833 Basic UDI-DI 08033945938833UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033945938833 UDI-DI Date8 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172198 Date17 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033945938833 registered 17 Jul 2026 Active
  • FDA 510(k) K172198 decided 17 Oct 2017 Active
  • FDA GUDID UDI-DI 08033945938833 listed 8 Jun 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172198
  2. Listed FDA GUDID 08033945938833
  3. Registered EUDAMED B-08033945938833

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  • Withdrawn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
OptiScan
Generic name
Skin laser scanner
Model / reference
OAM001857, OptiScan
Primary DI / UDI-DI
08033945938833
Basic UDI-DI
B-08033945938833
510(k) Number
FDA product code
GEX
EMDN code
Z12011019 Multi–platform laser
GMDN term
Skin laser scanner
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: Skin laser scanner

Cleared under the same submission (K172198)

Similar devices

Also classified as Skin laser scanner.

Similar devices in this category

Other devices filed under MULTI–PLATFORM LASER.

Other devices from Quanta System SpA

See all devices from Quanta System SpA →

Properties

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