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NeoGen 25mm 3x Nozzle (Black)

by Energist, Ltd.

NeoGen 25mm 3x Nozzle (Black) (830-058) is a nitrogen plasma skin surface treatment system (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) and listed in FDA GUDID since 2 Apr 2019 (UDI-DI 05060440520242), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK221873 Date12 Jan 2023DecidedStatusActive
United StatesGUDID listing Number05060440520242 UDI-DI Date2 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221873 decided 12 Jan 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05060440520242 listed 2 Apr 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132754
  2. Listed FDA GUDID 05060440520242
  3. Cleared FDA 510(k) K221873

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NeoGen
Generic name
Nitrogen plasma skin surface treatment system
Model / Ref / Catalog
NeoGen 25mm 3x Nozzle (Black), 830-058
Primary DI / UDI-DI
05060440520242
510(k) Number
FDA product code
GEI
GMDN term
Nitrogen plasma skin surface treatment system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Energist, Ltd.

See all devices from Energist, Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)