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Sign in to claim this brandENDYMED MEDICAL LTD
US
Last updated May 24, 2026
What ENDYMED MEDICAL LTD makes
The company manufactures multi-modality skin and body contouring systems designed for professional and home use, including radio-frequency devices for non-invasive skin tightening and treatment. Professional-grade micro-needling handpieces and laser systems are also produced, alongside dermatological diode lasers and applicators for targeted skin surface treatments. Topical coupling gels are included to enhance the performance of these devices during procedures. Examples include handheld RF systems like the EndyMed PRO 85W and micro-needling kits such as the NEWA PLUS.
These devices fall under FDA Class II regulation, requiring premarket notification (510(k)) or de novo clearance for market authorisation. They are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, ensuring compliance with US regulatory 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 Endymed Medical Ltd manufacture?
Endymed Medical Ltd specializes in multi-modality skin and body contouring systems, including professional and home-use radio-frequency (RF) devices for non-invasive skin tightening and treatment. Their product line also includes professional-grade micro-needling handpieces and laser systems, such as dermatological diode lasers and applicators for targeted skin surface treatments. Topical coupling gels are provided to improve device performance during procedures. Examples include handheld RF systems like the EndyMed PRO 85W and micro-needling kits like the NEWA PLUS.
Where is Endymed Medical Ltd based?
Endymed Medical Ltd is based in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices must comply with US-specific requirements like FDA classification and listing.
Which regulatory registries list Endymed Medical Ltd’s devices?
Endymed Medical Ltd’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are critical for tracking compliance with US regulatory requirements, ensuring transparency in device authorisation and market availability.
How are Endymed Medical Ltd’s devices classified under FDA regulations?
Endymed Medical Ltd’s devices fall under FDA Class II classification. This classification typically requires premarket notification (510(k)) or de novo clearance before they can be legally marketed in the US, as these devices pose moderate risk and require specific validation to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- endymed.com
- —
- —
- [email protected]
- Phone
- 1-855-363-9633
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 531958689
Catalogue (55)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fractional Skin Resurfacing (fsr) Applicator | K101510 | FDA 510(k) | Class II | Active |
| EndyMed Contour Handpiece | K161199 | FDA 510(k) | Class II | Active |
| Intensif | K130501 | FDA 510(k) | Class II | Active |
| Newa Skin Therapy System | DEN150005 | FDA 510(k) | Class II | Active |
| PURE Laser | K222369 | 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.
- Endymed Medical Ltd Caesarea Northern · IL FEI 3008085016