Solio Alfa +
Solio Alfa + (7290017992006) is a medium-wave diathermy treatment system generator (FDA Class II) made by Home Skinovations, Ltd., cleared under FDA 510(k) K152087 on 29 Jul 2016 and listed in FDA GUDID since 6 May 2019 (UDI-DI 17290017992003), 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 | Number17290017992003 | Date6 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152087 | Date29 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 17290017992003
- FDA 510(k) database K152087
Across registries
- FDA 510(k) K152087 decided 29 Jul 2016 Active
- FDA GUDID UDI-DI 17290017992003 listed 6 May 2019 Listed
Timeline
- Cleared FDA 510(k) K152087
- Listed FDA GUDID 17290017992003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Solio
- Generic name
- Medium-wave diathermy treatment system generator
- Model / Ref / Catalog
- Solio Alfa +, 7290017992006
- Primary DI / UDI-DI
- 17290017992003
- 510(k) Number
- FDA product code
- GEI, ILY
- GMDN term
- Medium-wave diathermy treatment system generator
- Device class
- Class II
- Regulation number
- 878.4400, 890.5500
- GUDID distribution status
- In Commercial Distribution
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