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NeoGen 5mm 1x Nozzle (Grey)

by Energist, Ltd.

NeoGen 5mm 1x Nozzle (Grey) (830-033) 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) K132754 on 12 Dec 2013 and listed in FDA GUDID since 3 Apr 2019 (UDI-DI 05060440520211), 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

510(k) K132754

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060440520211 UDI-DI Date3 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK132754 Date12 Dec 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132754 decided 12 Dec 2013 Active
  • FDA GUDID UDI-DI 05060440520211 listed 3 Apr 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132754
  2. Listed FDA GUDID 05060440520211

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  • Withdrawn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 5mm 1x Nozzle (Grey), 830-033
Primary DI / UDI-DI
05060440520211
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

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
  • Manufacturing date
Other properties (11, all answered No)