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Bioxel

by Ami Inc.

Ref BIOXEL

Bioxel is a device classified as Class IIb in the EU and Class II in the US made by Ami Inc., registered in EUDAMED on 2 Feb 2023 (Basic UDI-DI B-08800042100018), cleared under FDA 510(k) K173359 on 5 Jul 2018 and listed in FDA GUDID since 15 Jun 2021 (UDI-DI 08800042100018), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173359

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800042100018 Basic UDI-DI 08800042100018UDI-DIDate2 Feb 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08800042100018 UDI-DI Date15 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173359 Date5 Jul 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800042100018 registered 2 Feb 2023 Active
  • FDA 510(k) K173359 decided 5 Jul 2018 Active
  • FDA GUDID UDI-DI 08800042100018 listed 15 Jun 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173359
  2. Listed FDA GUDID 08800042100018
  3. Registered EUDAMED B-08800042100018

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  • Withdrawn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

Generic name
Dermatological carbon dioxide laser system
Device name
Fractional CO2 Laser
Model / reference
BIOXEL
Primary DI / UDI-DI
08800042100018
Basic UDI-DI
B-08800042100018
510(k) Number
FDA product code
GEX
EMDN code
Z12011005 Carbon dioxide surgical laser
GMDN term
Dermatological carbon dioxide laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
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.

Manufacturer details

EUDAMED SRN
KR-MF-000017522
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under CARBON DIOXIDE SURGICAL LASER.

Other devices from Ami Inc.

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Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)