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Neogen Handpiece Blk

by Energist, Ltd.

Ref 830-009

Neogen Handpiece Blk (830-009) is a nitrogen plasma skin surface treatment system (EU MDR Class IIb; EU MDR 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 7 Apr 2022 (Basic UDI-DI B-05060440520105) and listed in FDA GUDID since 13 May 2021 (UDI-DI 05060440520105), active as of 23 Oct 2026.

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

CE MDR 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) K221873

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK221873 Date12 Jan 2023DecidedStatusActive
European UnionCE/MDR EUDAMED NumberB-05060440520105 Basic UDI-DI 05060440520105UDI-DIDate7 Apr 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-05060440520105 Basic UDI-DI 05060440520105UDI-DIDate7 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05060440520105 UDI-DI Date13 May 2021ListedStatusListed 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-05060440520105 registered 7 Apr 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05060440520105 listed 13 May 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K132754
  2. Listed FDA GUDID 05060440520105
  3. Registered EUDAMED B-05060440520105
  4. Cleared FDA 510(k) K221873

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Neogen
Generic name
Nitrogen plasma skin surface treatment system
Device name
NeoGen PSR Handpiece Black
NeoGen Handpiece
Model / Ref / Catalog
830-009, Handpiece Blk
Primary DI / UDI-DI
05060440520105
Basic UDI-DI
B-05060440520105, 506044052NeoGen-NA-001GM
Direct marketing DI
05060440520105
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
830-009
GUDID
Handpiece Blk
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.

Related devices

Category: Nitrogen plasma skin surface treatment system

Cleared under the same submission (K132754)

and 5 more cleared under K132754

Cleared under the same submission (K221873)

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
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)