Data / Medical devices / Israel / Formatk Systems Ltd.
Formatk Systems Ltd.: FDA-registered device maker in Tirat Hacarmel Northern, Israel, 4 510(k) clearances
Formatk Systems Ltd. is registered with the FDA (registration 3011670002) in Tirat Hacarmel Northern, Israel. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 11, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011670002
- Address
- 3 Hayozma St., Tirat Hacarmel Northern, Israel, 3903203
- Owner or operator
- Formatk Systems, Ltd. (10051579)
- Roles
- Manufacturer
- First device listed
- April 7, 2016
- Registered through
- 2026
- Brand names listed
- ALD, Alpha, DioBreeze, Forma System, Forma Light System, HR-Max, HR-Mini, LLD, MAGMA SPARK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2018 | K183307 | Magma Spark Pro (Magma Spark Plus, Alpha) | GEX | Substantially Equivalent | Formatk Systems , Ltd. | accessdata.fda.gov |
| November 9, 2016 | K162781 | Magma Spark | GEX | Substantially Equivalent | Formatk Systems , Ltd. | accessdata.fda.gov |
| April 15, 2016 | K160195 | Forma System, Forma Light System | ONF | Substantially Equivalent | Formatk Systems , Ltd. | accessdata.fda.gov |
| April 6, 2016 | K153566 | Magma System | GEX | Substantially Equivalent | Formatk Systems , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Brush, Dermabrasion, Powered
Updated December 11, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.