Endymed Medical L T D

FDA Filings

This page includes the latest FDA filings for Endymed Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008085016
• FEI Number: 3008085016
• Name: Tova Rivnay
• Owner & Operator: Endymed Medical Ltd
• Contact Address: 12 Leshem Street North Industrial Park; Caesarea IL-Z Ha Zafon 3088900 IL
• Official Correspondent:
  • Yoram Levy
  • 972-4-6388837-x
• US Agent:
  • Tova Rivnay
  • Qsite
  • 512 5354930
  • 512 5356103
  • yoram@qsitemed.com
• Importing Logistics Registration:
  • Importer: EndyMed Medical Inc
  • Address: 790 Madison Avenue Suite 402 ; New York, NY 10065 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 77 Dorcar Rd ; Newton, MA 02459 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07290016814668 ENDYMED MEDICAL LTD	PURE DentA ND_PRD00480-00	2024-11-14
GUDID 07290016814477 ENDYMED MEDICAL LTD	EndyMed PRO MAX, Contour MAX Handpiece ND_PRD00467-00	2024-05-24
GUDID 07290016814460 ENDYMED MEDICAL LTD	EndyMed PRO MAX,Mini Shaper MAX Handpiece ND_PRD00468-00	2024-05-24
GUDID 07290016814453 ENDYMED MEDICAL LTD	EndyMed PRO MAX,Shaper MAX Handpiece ND_PRD00466-00	2024-05-24
GUDID 07290016814446 ENDYMED MEDICAL LTD	EndyMed PRO MAX, iFine MAX Handpiece ND_PRD00469-00	2024-05-24
GUDID 07290016814439 ENDYMED MEDICAL LTD	EndyMed PRO MAX, FSR MAX Handpiece ND_PRD00471-00	2024-05-24
GUDID 07290016814422 ENDYMED MEDICAL LTD	EndyMed PRO MAX, Small MAX Handpiece ND_PRD00470-00	2024-05-24
GUDID 07290016814415 ENDYMED MEDICAL LTD	endyMed PRO MAX, Intensif MAX Handpiece ND_PRD00462-00	2024-05-24
GUDID 07290016814408 ENDYMED MEDICAL LTD	EndyMed PRO MAX, System, 110V ND_PRD00464-00	2024-05-24
GUDID 17290014660127 ENDYMED MEDICAL LTD	NEWA+, Kit, US, PINK ND_PRD00457-00	2023-11-28
GUDID 17290016814351 ENDYMED MEDICAL LTD	EndyGel ND_PRD00016	2023-07-12
GUDID 07290016814378 ENDYMED MEDICAL LTD	PURE Laser, EPL810 HP ND_PRD00459-00	2023-06-27
GUDID 07290016814361 ENDYMED MEDICAL LTD	PURE Laser, System ND_PRD00456-00	2023-06-27
PMN K222369 Endymed Medical, Ltd.	PURE Laser	2022-10-07
GUDID 17290014660110 ENDYMED MEDICAL LTD	NEWA PLUS Kit ND_PRD00450-00	2022-01-17
GUDID 07290014660083 ENDYMED MEDICAL LTD	NEWA Kit ND_PRD00446-00	2021-10-01
GUDID 17290014660028 ENDYMED MEDICAL LTD	NEWA PLUS Kit ND_PRD00439-00	2021-05-06
GUDID 07290014660014 ENDYMED MEDICAL LTD	NEWA PLUS Kit ND_PRD00438-00	2021-04-28
GUDID 17290014660967 ENDYMED MEDICAL LTD	NEWA Kit ND_PRD00432-00	2019-03-21
GUDID 17290014660837 ENDYMED MEDICAL LTD	NEWA Kit ND_PRD00426-00	2019-03-21
GUDID 17290014660455 ENDYMED MEDICAL LTD	NEWA Kit ND_PRD00200	2019-03-21
GUDID 17290014660004 ENDYMED MEDICAL LTD	NEWA Kit ND_PRD00126	2019-03-21
GUDID 07290016814347 ENDYMED MEDICAL LTD	EndyMed FSR 10 Tips Package - sterile ND_PRD00435	2019-03-21
GUDID 07290016814330 ENDYMED MEDICAL LTD	EndyMed Intensif 10 pack tips package ND_PRD00177	2019-03-21
GUDID 07290016814323 ENDYMED MEDICAL LTD	EndyMed Intensif 10 Tips Package ND_PRD00045	2019-03-21
GUDID 07290016814293 ENDYMED MEDICAL LTD	EndyMed Pure 85W system 220V ND_PRD00088-01	2019-03-21
GUDID 07290016814286 ENDYMED MEDICAL LTD	EndyMed Pure system 220V ND_PRD00077	2019-03-21
GUDID 07290016814279 ENDYMED MEDICAL LTD	EndyMed Pure 2.0 system 110V PURE logo ND_PRD00413-00	2019-03-21
GUDID 07290016814231 ENDYMED MEDICAL LTD	EndyMed Pure 2.0 system 220V PURE logo ND_PRD00208	2019-03-21
GUDID 07290016814224 ENDYMED MEDICAL LTD	EndyMed PRO 85W System Face 220V ND_PRD00009_F_F	2019-03-21
GUDID 07290016814217 ENDYMED MEDICAL LTD	EndyMed Pure Intensif Handpiece ND_PRD00235	2019-03-21
GUDID 07290016814200 ENDYMED MEDICAL LTD	EndyMed PRO Intensif Handpiece ND_PRD00185	2019-03-21
GUDID 07290016814194 ENDYMED MEDICAL LTD	EndyMed PRO 85W System Body 2200V ND_PRD00009_F_B	2019-03-21
GUDID 07290016814187 ENDYMED MEDICAL LTD	EndyMed PRO 85W System 220V ND_PRD00009_F	2019-03-21
GUDID 07290016814170 ENDYMED MEDICAL LTD	EndyMed PRO 85W System Face 110V ND_PRD00006_F_F	2019-03-21
GUDID 07290016814163 ENDYMED MEDICAL LTD	EndyMed PRO 85W System Body 110V ND_PRD00006_F_B	2019-03-21
GUDID 07290016814156 ENDYMED MEDICAL LTD	EndyMed PRO 85W System 110V ND_PRD00006_F	2019-03-21
GUDID 07290016814149 ENDYMED MEDICAL LTD	EndyMed Pro Shaper Handpiece ND_PRD00093	2019-03-21
GUDID 07290016814132 ENDYMED MEDICAL LTD	EndyMed Pro iFine Handpiece ND_PRD00036	2019-03-21
GUDID 07290016814125 ENDYMED MEDICAL LTD	EndyMed Pro FSR Handpiece ND_PRD00013	2019-03-21
GUDID 07290016814101 ENDYMED MEDICAL LTD	EndyMed Pro Small Handpiece ND_PRD00005	2019-03-21
GUDID 07290016814088 ENDYMED MEDICAL LTD	EndyMed PRO Contour Handpiece ND_PRD00180	2019-03-21
GUDID 07290016814071 ENDYMED MEDICAL LTD	EndyMed PRO mini-shaper Handpiece ND_PRD00179	2019-03-21
GUDID 07290016814057 ENDYMED MEDICAL LTD	EndyMed Pure mini-shaper Handpiece ND_PRD00178	2019-03-21
GUDID 07290016814040 ENDYMED MEDICAL LTD	EndyMed Pure Shaper Handpiece ND_PRD00097	2019-03-21
GUDID 07290016814033 ENDYMED MEDICAL LTD	EndyMed Pure iFine Handpiece ND_PRD00075	2019-03-21
GUDID 07290016814026 ENDYMED MEDICAL LTD	EndyMed Pure FSR Handpiece ND_PRD00141	2019-03-21
GUDID 07290016814019 ENDYMED MEDICAL LTD	EndyMed Pure Small Handpiece ND_PRD00074	2019-03-21
PMN K161199 | PBX Tova Rivnay [Endymed Medical Ltd]	Contour Handpiece	2018-11-26
PMN K161715 | GYB Tova Rivnay [Endymed Medical Ltd]	EndyGel	2017-02-08
PMN K161715 EndyMed Medical Ltd.	EndyGel	2017-02-07
PMN DEN150005 | PAY Tova Rivnay [Endymed Medical Ltd]	Over the Counter Newa Skin Therapy System	2016-11-23
PMN DEN150005 | PAY Tova Rivnay [Endymed Medical Ltd]	Newa	2016-11-23
PMN DEN150005 | PAY Tova Rivnay [Endymed Medical Ltd]	Newa Plus	2016-11-23
PMN K161199 ENDYMED MEDICAL LTD.	EndyMed Contour Handpiece	2016-08-01
De Novo DEN150005 EndyMed Medical Ltd.	Newa Skin Therapy System	2015-12-18
PMN K130501 | OUH Tova Rivnay [Endymed Medical Ltd]	Intensif	2014-03-19
PMN K130501 | OUH Tova Rivnay [Endymed Medical Ltd]	Ilooda Secret	2014-03-19
PMN K130501 | GEI Tova Rivnay [Endymed Medical Ltd]	Intensif	2014-03-19
PMN K130501 | GEI Tova Rivnay [Endymed Medical Ltd]	Ilooda Secret	2014-03-19
PMN K130501 ENDYMED MEDICAL LTD	INTENSIF	2014-03-13
PMN K130793 | GEI Tova Rivnay [Endymed Medical Ltd]	EndyMed Newa	2013-12-24
PMN K041994 | GEX Tova Rivnay [Endymed Medical Ltd]	MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM	2012-11-02
PMN K041569 | ILY Tova Rivnay [Endymed Medical Ltd]	CLEAR100 PHOTOTHERAPY SYSTEM	2012-11-02
PMN K041569 | GEX Tova Rivnay [Endymed Medical Ltd]	CLEAR100 PHOTOTHERAPY SYSTEM	2012-11-02
PMN K033183 | ILY Tova Rivnay [Endymed Medical Ltd]	RECLEAR PHOTOTHERAPY SYSTEM	2012-11-02
PMN K033183 | GEX Tova Rivnay [Endymed Medical Ltd]	RECLEAR PHOTOTHERAPY SYSTEM	2012-11-02
PMN K032383 | GEX Tova Rivnay [Endymed Medical Ltd]	MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM	2012-11-02
PMN K030338 | GEX Tova Rivnay [Endymed Medical Ltd]	ICLEAR PHOTOTHERAPY SYSTEM	2012-11-02
PMN K013623 | GEX Tova Rivnay [Endymed Medical Ltd]	CLEARLIGHT PHOTOTHERAPHY SYSTEM	2012-11-02
PMN K120513 | OUH Tova Rivnay [Endymed Medical Ltd]	iFine	2012-06-16
PMN K120513 | OUH Tova Rivnay [Endymed Medical Ltd]	Pure by EndyMed	2012-06-16
PMN K120513 | OUH Tova Rivnay [Endymed Medical Ltd]	Glow by EndyMed	2012-06-16
PMN K120513 | OUH Tova Rivnay [Endymed Medical Ltd]	Eclipse Firma	2012-06-16
PMN K120513 | GEI Tova Rivnay [Endymed Medical Ltd]	iFine	2012-06-16
PMN K120513 | GEI Tova Rivnay [Endymed Medical Ltd]	Pure by EndyMed	2012-06-16
PMN K120513 | GEI Tova Rivnay [Endymed Medical Ltd]	Glow by EndyMed	2012-06-16
PMN K120513 | GEI Tova Rivnay [Endymed Medical Ltd]	Eclipse Firma	2012-06-16
PMN K120513 ENDYMED MEDICAL LTD	GLOW BY ENDYMED	2012-05-08
PMN K101510 | OUH Tova Rivnay [Endymed Medical Ltd]	Fractional Skin Resurfacing (FSR)	2011-05-15
PMN K101510 ENDYMED MEDICAL LTD	FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR	2011-02-17
PMN K083461 | GEI Tova Rivnay [Endymed Medical Ltd]	iFine	2009-12-04
PMN K083461 | GEI Tova Rivnay [Endymed Medical Ltd]	Shaper3D	2009-12-04
PMN K083461 | GEI Tova Rivnay [Endymed Medical Ltd]	Endymed Pro Skin Treatment System	2009-12-04

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091646878	Hong Kong,Hong Kong -> Los Angeles, California	SKIN REFRESH BEAUTY INSTRUMENT . . . . .	100 CTN
2020081841432	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	4 PKG
2019113054392	Hong Kong,Hong Kong -> Long Beach, California	SKIN REFRESH BEAUTY INSTRUMENT KIT . . . . .	169 CTN
2019101525347	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	NEWA LIFT ACTIVATOR GEL AND DELICATE SKIN GEL .	6 PKG
2019062042442	Hong Kong,Hong Kong -> Long Beach, California	SKIN REFRESH BEAUTY INSTRUMENT . . . . .	200 CTN
2019040437670	Hong Kong,Hong Kong -> Long Beach, California	SKIN REFRESH BEAUTY INSTRUMENT . . . . .	200 CTN
2018052623407	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	LIFT ACTIVATOR GEL HS 330499906	2 PLT