PlaDuo PRO System
PlaDuo PRO System is a nitrogen plasma skin surface treatment system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by shenb Co., Ltd., cleared under FDA 510(k) K232223 on 24 Oct 2023 and listed in FDA GUDID since 29 Apr 2025 (UDI-DI 08800017101422), active as of 31 May 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800017101422 | Date29 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232223 | Date24 Oct 2023 | StatusActive |
Official records
- AccessGUDID record 08800017101422
- FDA 510(k) database K232223
Across registries
- FDA 510(k) K232223 decided 24 Oct 2023 Active
- FDA GUDID UDI-DI 08800017101422 listed 29 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K232223
- Listed FDA GUDID 08800017101422
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nitrogen plasma skin surface treatment system
- Model / reference
- PlaDuo PRO System
- Primary DI / UDI-DI
- 08800017101422
- 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
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