NeoGen 5mm 3x Nozzle (Black)
NeoGen 5mm 3x Nozzle (Black) (830-057) 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 05060440520235), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221873 | Date12 Jan 2023 | StatusActive |
| United States | GUDID listing | Number05060440520235 | Date2 Apr 2019 | StatusListed |
Official records
- AccessGUDID record 05060440520235
- FDA 510(k) database K221873
- FDA 510(k) database K132754
Across registries
- FDA 510(k) K221873 decided 12 Jan 2023 Active
- FDA GUDID UDI-DI 05060440520235 listed 2 Apr 2019 Listed
Timeline
- Cleared FDA 510(k) K132754
- Listed FDA GUDID 05060440520235
- Cleared FDA 510(k) K221873
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeoGen
- Generic name
- Nitrogen plasma skin surface treatment system
- Model / Ref / Catalog
- NeoGen 5mm 3x Nozzle (Black), 830-057
- Primary DI / UDI-DI
- 05060440520235
- 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
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