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NeoGen

by Energist 3 variants

Ref 830-006

NeoGen (830-006) is a nitrogen plasma skin surface treatment system (EU MDD Class IIb; EU MDD Class I; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Energist, Ltd., cleared under FDA 510(k) K221873 on 12 Jan 2023 (1 earlier submission), registered in EUDAMED on 5 Apr 2022 (Basic UDI-DI B-05060440520198) and listed in FDA GUDID since 3 Apr 2019 (UDI-DI 05060440520198), 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) K221873

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK221873 Date12 Jan 2023DecidedStatusActive
European UnionCE/MDD EUDAMED NumberB-05060440520198 Basic UDI-DI 05060440520198UDI-DIDate5 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05060440520198 UDI-DI Date3 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K221873 decided 12 Jan 2023 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI B-05060440520198 registered 5 Apr 2022 Active
  • FDA GUDID UDI-DI 05060440520198 listed 3 Apr 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K132754
  2. Listed FDA GUDID 05060440520198
  3. Registered EUDAMED B-05060440520198
  4. Cleared FDA 510(k) K221873

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  • Withdrawn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
NeoGen EUDAMEDGUDID
NeoGen 5mm Nozzle EUDAMED
Generic name
Nitrogen plasma skin surface treatment system
Device name
NeoGen 5mm Nozzle Blk
NeoGen Nozzle
Model / Ref / Catalog
830-006, NeoGen 5mm 1x Nozzle (Black)
Primary DI / UDI-DI
05060440520198
Basic UDI-DI
B-05060440520198, 506044052NeoGen-NZ-001R8
510(k) Number
FDA product code
GEI
EMDN code
Z12040203 Dermal regeneration equipment
GMDN term
Nitrogen plasma skin surface treatment system
Device class
Class IIb EUDAMED
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
830-006
GUDID
NeoGen 5mm 1x Nozzle (Black)
Device classEUDAMED
Class IIb
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb and Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Manufacturer details

EUDAMED SRN
GB-MF-000021765
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under DERMAL REGENERATION EQUIPMENT.

Other devices from Energist, Ltd.

See all devices from Energist, Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)