Hand Piece H/S_03
Hand Piece H/S_03 is a Class II device made by VIOL Co., Ltd., cleared under FDA 510(k) K180872 on 11 Oct 2018 and listed in FDA GUDID since 11 Jul 2025 (UDI-DI 08809502330446), 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 | GUDID listing | Number08809502330446 | Date11 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180872 | Date11 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 08809502330446
- FDA 510(k) database K180872
Across registries
- FDA 510(k) K180872 decided 11 Oct 2018 Active
- FDA GUDID UDI-DI 08809502330446 listed 11 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K180872
- Listed FDA GUDID 08809502330446
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hand Piece
- Generic name
- Electrosurgical system
- Model / reference
- H/S_03
- Primary DI / UDI-DI
- 08809502330446
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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