Magma Spark
510(k) K162781
Magma Spark is a Class II device made by Formatk Systems Ltd, cleared under FDA 510(k) K162781 on 9 Nov 2016, active as of 22 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 | NumberK162781 | Date9 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K162781
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Formatk Systems , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162781
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DioBreeze FS80020 | FS80020 / FS80020 | 07290016681079 | — | On the market |
| HR-Max FS80022 | FS80022 / FS80022 | 07290016681444 | — | On the market |
| HR-Mini FS80021 | FS80021 / FS80021 | 07290016681437 | — | On the market |
| Magma Spark FS80000 | FS80000 / FS80000 | 07290016681031 | — | On the market |
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