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ENDYMED MEDICAL LTD

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-855-363-9633
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 531958689

Catalogue (55)

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Device	Model / Reference	Registries	Class	Status
EndyMed PRO 85W System Body 110V	PRO 85W System Body 110V	FDA UDI	Class II	Active
EndyMed PRO 85W System 110V	PRO 85W System 110V	FDA UDI	Class II	Active
EndyMed Pure Shaper Handpiece	Shaper Handpiece	FDA UDI	Class II	Active
EndyMed PRO mini-shaper Handpiece	mini-shaper Handpiece	FDA UDI	Class II	Active
EndyMed PRO 85W System Face 220V	PRO 85W System Face 220V	FDA UDI	Class II	Unknown
EndyMed PRO MAX, Small MAX Handpiece	Small MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed PRO MAX, iFine MAX Handpiece	iFine MAX Handpiece	FDA UDI	Class II	Unknown
NEWA Kit	1.5, pink	FDA UDI	Class II	Active
EndyMed Pure 2.0 system 220V PURE logo	Pure 2.0 system 220V PURE logo	FDA UDI	Class II	Unknown
NEWA Kit	1.5, Black	FDA UDI	Class II	Active
EndyMed Pure iFine Handpiece	iFine Handpiece	FDA UDI	Class II	Active
NEWA PLUS Kit	Plus, Lavender	FDA UDI	Class II	Active
EndyMed Pure mini-shaper Handpiece	mini-shaper Handpiece	FDA UDI	Class II	Active
endyMed PRO MAX, Intensif MAX Handpiece	Intensif MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed Pro Shaper Handpiece	Pro Shaper Handpiece	FDA UDI	Class II	Active
EndyMed Pure system 220V	Pure system 220V	FDA UDI	Class II	Unknown
EndyMed Pro iFine Handpiece	Pro iFine Handpiece	FDA UDI	Class II	Active
PURE Laser, System	PURE Laser	FDA UDI	Class II	Active
EndyMed PRO Intensif Handpiece	Intesif Handpiece	FDA UDI	Class II	Active
NEWA PLUS Kit	Plus, Blue	FDA UDI	Class II	Unknown
EndyMed PRO MAX, FSR MAX Handpiece	FSR MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed Pure Intensif Handpiece	Intensif Handpiece	FDA UDI	Class II	Active
EndyMed Pro FSR Handpiece	Pro FSR Handpiece	FDA UDI	Class II	Active
PURE DentA	PURE DentA 110V	FDA UDI	Class II	Active
EndyMed PRO Contour Handpiece	Countour Handpiece	FDA UDI	Class II	Active
EndyMed Intensif 10 Tips Package	Intensif 10 Tips Package	FDA UDI	Class II	Active
NEWA+, Kit, US, PINK	Plus, PINK	FDA UDI	Class II	Active
PURE Laser, EPL810 HP	EPL810 HP	FDA UDI	Class II	Active
EndyMed Pro Small Handpiece	Pro Small Handpiece	FDA UDI	Class II	Active
NEWA Kit	1.5, Ivory demo	FDA UDI	Class II	Unknown
NEWA Kit	1.5, Ivory	FDA UDI	Class II	Active
EndyMed Pure 2.0 system 110V PURE logo	Pure 2.0 system 110V PURE logo	FDA UDI	Class II	Active
EndyMed Pure Small Handpiece	Small Handpiece	FDA UDI	Class II	Active
EndyMed Pure FSR Handpiece	FSR Handpiece	FDA UDI	Class II	Active
NEWA PLUS Kit	Plus, Gold	FDA UDI	Class II	Unknown
EndyMed PRO MAX, Contour MAX Handpiece	Contour MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed FSR 10 Tips Package - sterile	FSR 10 Tips Package - sterile	FDA UDI	Class II	Active
EndyMed PRO 85W System Face 110V	PRO 85W System Face 110V	FDA UDI	Class II	Active
EndyGel	EndyGel 350 ml	FDA UDI	Class II	Active
EndyMed PRO MAX, Shaper MAX Handpiece	Shaper MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed Intensif 10 pack tips package	Intensif 10 pack tips package	FDA UDI	Class II	Active
EndyMed PRO 85W System Body 2200V	PRO 85W System Body 2200V	FDA UDI	Class II	Unknown
EndyMed PRO 85W System 220V	PRO 85W System 220V	FDA UDI	Class II	Unknown
EndyMed PRO MAX, System, 110V	Pro Max System 110V white	FDA UDI	Class II	Unknown
EndyMed PRO MAX, Mini Shaper MAX Handpiece	Mini Shaper MAX Handpiece	FDA UDI	Class II	Unknown
EndyMed Pure 85W system 220V	Pure 85W system 220V	FDA UDI	Class II	Unknown
NEWA Kit	1.5, red	FDA UDI	Class II	Active
EndyGel	K161715	FDA 510(k)	Class II	Active
Glow By Endymed	K120513	FDA 510(k)	Class II	Active
EndyMed PRO MAX	K242996	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