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Sign in to claim this brandFORMATK SYSTEMS LTD
US
Last updated May 23, 2026
What FORMATK SYSTEMS LTD makes
The company manufactures dermatological and cosmetic treatment devices, including diode lasers, radio-frequency applicators, and light-energy systems for skin surface treatments. Their portfolio also includes multi-modality treatment systems, laser beam guiding handpieces, and electromechanical transport trolleys for medical and aesthetic procedures. Skin abrasion units and professional red-light phototherapy systems are also part of their offerings. These devices are designed for professional use in clinical and cosmetic settings.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Formatk Systems Ltd manufacture?
Formatk Systems Ltd specializes in dermatological and cosmetic treatment devices. Their portfolio includes diode lasers, radio-frequency applicators (like bipolar skin contouring systems), light-energy skin treatment systems, multi-modality treatment systems, laser beam guiding handpieces, electromechanical transport trolleys, skin abrasion units, and professional red-light phototherapy systems. These devices are designed for professional use in clinical and aesthetic settings, addressing skin treatments such as contouring, resurfacing, and therapeutic lighting.
Where is Formatk Systems Ltd based, and how does that affect its regulatory standing?
Formatk Systems Ltd is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulations. The company’s products are listed in the FDA’s 510(k) and UDI registries, which are key databases for tracking and authorizing medical devices in the U.S. This ensures compliance with U.S. requirements for device authorization, as individual devices must meet FDA criteria for market clearance.
Which regulatory registries list Formatk Systems Ltd’s devices, and why does this matter?
Formatk Systems Ltd’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) registry documents premarket submissions demonstrating that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and transparency in the supply chain. Listing in these registries confirms that the devices comply with U.S. authorization requirements, helping healthcare providers verify regulatory status before use.
How are Formatk Systems Ltd’s devices classified under FDA regulations?
Formatk Systems Ltd’s devices are classified under FDA categories Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and technological complexity. For example, dermatological lasers or radio-frequency applicators may fall into Class II due to their precision and potential for tissue interaction, whereas simpler systems like transport trolleys might be Class I.
What kinds of professional settings use Formatk Systems Ltd’s devices?
Formatk Systems Ltd’s devices are primarily designed for professional use in clinical and cosmetic settings, such as dermatology clinics, aesthetic medicine practices, and medical spas. Their product range—including lasers, radio-frequency systems, and light therapy devices—targets procedures like skin resurfacing, contouring, hair removal, and therapeutic treatments. These systems are engineered for controlled, high-precision applications where trained professionals administer treatments to patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 532396673
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Magma Spark Cart | FS80001 | FDA UDI | Class I | Active |
| B-Hr | FS10006 | FDA UDI | Class II | Active |
| Magma | FS70000 | FDA UDI | Class II | Active |
| F-Hr* | FS10003 | FDA UDI | Class II | Active |
| St | FS10011 | FDA UDI | Class II | Active |
| Alpha | FS90000 | FDA UDI | Class II | Active |
| Magma Spark Plus | FS90000 | FDA UDI | Class II | Active |
| DioBreeze | FS80020 | FDA UDI | Class II | Active |
| Forma Light | FS60000 | FDA UDI | Class II | Active |
| Forma | FS10000 | FDA UDI | Class II | Active |
| F-Hr | FS10002 | FDA UDI | Class II | Active |
| Magma Spark | FS80000 | FDA UDI | Class II | Active |
| S-530 | FS90012 | FDA UDI | Class II | Active |
| HR-Mini | FS80021 | FDA UDI | Class II | Active |
| F-Ac | FS10005 | FDA UDI | Class II | Active |
| Ald | FS70001 | FDA UDI | Class II | Active |
| Plg | FS10009 | FDA UDI | Class I | Active |
| Hr | FS60002 | FDA UDI | Class II | Active |
| HR-Max | FS80022 | FDA UDI | Class II | Active |
| DioBreeze Cart | FS80023 | FDA UDI | Class I | Active |
| F-Sr | FS10004 | FDA UDI | Class II | Active |
| Hr* | FS60003 | FDA UDI | Class II | Active |
| S-590 | FS90013 | FDA UDI | Class II | Active |
| Lld | FS70007 | FDA UDI | Class II | Active |
| iProElite | FS10000-3 | FDA UDI | Class II | Active |
| Forma Cart | FS10001 | FDA UDI | Class I | Active |
| B-Sr | FS10008 | FDA UDI | Class II | Active |
| L-530 | FS90014 | FDA UDI | Class II | Active |
| Sr | FS60001 | FDA UDI | Class II | Active |
| Sheerwave Plus | IPLaser 360 | FDA UDI | Class II | Active |
| Magma Spark Pro | FS90000 | FDA UDI | Class II | Active |
| S-430 | FS90011 | FDA UDI | Class II | Active |
| iProElite Cart | FS10001-3 | FDA UDI | Class I | Active |
| L-650 | FS90015 | FDA UDI | Class II | Active |
| B-Hr* | FS10007 | FDA UDI | Class II | Active |
| Forma System, Forma Light System | K160195 | FDA 510(k) | Class II | Active |
| Magma System | K153566 | FDA 510(k) | Class II | Active |
| Magma Spark Pro (Magma Spark Plus, Alpha) | K183307 | FDA 510(k) | Class II | Active |
| Magma Spark | K162781 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Formatk Systems Ltd. Tirat Hacarmel Northern · IL FEI 3011670002