Data / Medical devices / Israel / Endymed Medical Ltd

Endymed Medical Ltd: FDA-registered device maker in Caesarea Northern, Israel, 10 510(k) clearances

Name: Endymed Medical Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Endymed Medical Ltd is registered with the FDA (registration 3008085016) in Caesarea Northern, Israel. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 10, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008085016
Address: 12 Leshem Street North Industrial Park, Caesarea Northern, Israel, 3088900
Owner or operator: Endymed Medical Ltd (10030976)
Roles: Manufacturer
First device listed: December 4, 2009
Registered through: 2027
Brand names listed: Contour Handpiece, EndyGel, EndyMed PRO system with Small HP, iFine HP, mini-Shaper HP, Shaper HP, FSR Handpiece, Intensif HP, NEWA, NEWA/NEWA+, PRO MAX system with Small MAX HP, mini-Shaper MAX HP, Shaper MAX HP, and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	PAY	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Skin Resurfacing Rf Applicator	OUH	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
June 10, 2025	K242996	EndyMed PRO MAX	GEI	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
October 7, 2022	K222369	PURE Laser	GEX	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
February 7, 2017	K161715	EndyGel	GYB	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
August 1, 2016	K161199	EndyMed Contour Handpiece	PBX	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
December 18, 2015	DEN150005	Newa Skin Therapy System	PAY	Unknown	Endymed Medical, Ltd.	accessdata.fda.gov
March 13, 2014	K130501	INTENSIF	OUH	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
August 16, 2013	K130793	NEWA SKIN THERAPY SYSTEM	GEI	Substantially Equivalent	Endymion Medical, Ltd.	accessdata.fda.gov
May 8, 2012	K120513	GLOW BY ENDYMED	OUH	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
February 17, 2011	K101510	FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR	OUH	Substantially Equivalent	Endymed Medical, Ltd.	accessdata.fda.gov
July 24, 2009	K083461	IMAGINE TC SKIN THERAPY SYSTEM	GEI	Substantially Equivalent	Endymion Medical, Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 10, 2025. 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.