PlaDuo System
PlaDuo 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) K201735 on 14 Dec 2020 and listed in FDA GUDID since 28 Dec 2020 (UDI-DI 08800017100159), active as of 21 Oct 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 | Number08800017100159 | Date28 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201735 | Date14 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 08800017100159
- FDA 510(k) database K201735
Across registries
- FDA 510(k) K201735 decided 14 Dec 2020 Active
- FDA GUDID UDI-DI 08800017100159 listed 28 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K201735
- Listed FDA GUDID 08800017100159
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- Withdrawn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
- Primary DI / UDI-DI
- 08800017100159
- 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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