Magma System
510(k) K153566
Magma System is a Class II device made by Formatk Systems Ltd, cleared under FDA 510(k) K153566 on 6 Apr 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 | NumberK153566 | Date6 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K153566
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- Withdrawn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 K153566
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 | |||
|---|---|---|---|---|
| ALD FS70001 | FS70001 / FS70001 | 07290016681321 | — | On the market |
| B-HR FS10006 | FS10006 / FS10006 | 07290016681246 | — | On the market |
| B-HR* FS10007 | FS10007 / FS10007 | 07290016681253 | — | On the market |
| B-SR FS10008 | FS10008 / FS10008 | 07290016681260 | — | On the market |
| F-AC FS10005 | FS10005 / FS10005 | 07290016681239 | — | On the market |
| F-HR FS10002 | FS10002 / FS10002 | 07290016681208 | — | On the market |
| F-HR* FS10003 | FS10003 / FS10003 | 07290016681215 | — | On the market |
| F-SR FS10004 | FS10004 / FS10004 | 07290016681222 | — | On the market |
| FS70002 | FS70002 / FS70002 | 07290016681338 | — | On the market |
| HR FS60002 | FS60002 / FS60002 | 07290016681284 | — | On the market |
| HR* FS60003 | FS60003 / FS60003 | 07290016681291 | — | On the market |
| LLD FS70007 | FS7007 / FS70007 | 07290016681345 | — | On the market |
| Magma FS70000 | FS70000 / FS70000 | 07290016681024 | — | On the market |
| Sheerwave Plus IPLaser 360 | FS70020 / IPLaser 360 | 07290016681086 | — | On the market |
| SR FS60001 | FS60001 / FS60001 | 07290016681307 | — | On the market |
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