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Scar 3 Pro

by Deka M.E.L.A. SRL

Part of a family of 41 devices: see the family page

Ref F540A1

Scar 3 Pro (F540A1) is a skin laser scanner (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Deka M.E.L.A. SRL, cleared under FDA 510(k) K231309 on 2 Jun 2023, registered in EUDAMED on 16 Dec 2021 (Basic UDI-DI 803410851F49801KD) and listed in FDA GUDID since 4 Apr 2024 (UDI-DI 08034108512846), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K231309

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08034108512846 UDI-DI Date4 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK231309 Date2 Jun 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number803410851F49801KD Basic UDI-DI 08034108512846UDI-DIDate16 Dec 2021RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231309 decided 2 Jun 2023 Active
  • EUDAMED Basic UDI-DI 803410851F49801KD registered 16 Dec 2021 Active
  • FDA GUDID UDI-DI 08034108512846 listed 4 Apr 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 803410851F49801KD
  2. Cleared FDA 510(k) K231309
  3. Listed FDA GUDID 08034108512846

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Skin laser scanner
Device name
Scanning units for CO2 lasers
Model / reference
F540A1
Primary DI / UDI-DI
08034108512846
Basic UDI-DI
803410851F49801KD
510(k) Number
FDA product code
GEX
EMDN code
Z12011099 Laser surgery instruments - other
GMDN term
Skin laser scanner
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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-000007389

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - OTHER.

Other devices from Deka M.E.L.A. SRL

See all devices from Deka M.E.L.A. SRL →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)