Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012911444

FEI Number

3012911444

Entity Name

TAMUZ F.T.K. SOLUTIONS

City/State/Country

Afula Northern, IL

Establishment Address

Kibbutz Yizrael, Afula Northern 19350, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tamuz F.T.K. Solutions (Owner Number: 10060855)

Owner / Operator Contact Address

Kibbutz Yizrael, Afula, IL-NOTA 19350, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UltraPulse AcuPulse W CO2 Laser Systems UltraPulse CO2 Surgical and Aesthetic Lasers ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories Shield System Renaissance X System AcuPulse CO2 Laser System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-07-13
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-08-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-08-13
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-08-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-01-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-01-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-07-02
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-07-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-08-08

Official Correspondent

George Hattub

US Agent Details

George Hattub Business: Medicsense USA Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Tamuz F.T.K. Solutions

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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0001-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012911444. Last updated year: 2026. Please use registration number 3012911444 when referencing this establishment in official correspondence.