Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008085016

FEI Number

3008085016

Entity Name

ENDYMED MEDICAL LTD

City/State/Country

Caesarea Northern, IL

Establishment Address

12 Leshem Street, North Industrial Park, Caesarea Northern 3088900, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Endymed Medical Ltd (Owner Number: 10030976)

Owner / Operator Contact Address

12 Leshem Street, North Industrial Park, Caesarea, IL-Z 3088900, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101510

PMA Number

N/A

All Registered Proprietary Names

NEWA PURE Laser with EPL810 HP PRO MAX system with Small MAX HP, mini-Shaper MAX HP, Shaper MAX HP, iFine MAX HP, FSR MAX HP , Intensif MAX HP, Contour MAX HP NEWA/NEWA+ PURE 2 system with Small HP, iFine HP, mini-shaper HP, Shaper HP EndyGel Intensif HP Contour Handpiece FSR Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-12-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-11-12
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2025-07-31
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2025-07-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-31
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2016-11-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-16
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2012-06-16
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2017-02-08
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2014-03-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-03-19
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2018-11-26
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2011-05-15

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Endymed Medical Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008085016. Last updated year: 2026. Please use registration number 3008085016 when referencing this establishment in official correspondence.