Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011782009

FEI Number

3010666513

Entity Name

B.Y. MEDIMOR LTD

City/State/Country

Tiberias Northern, IL

Establishment Address

Tsivonit St. 1, Tiberias Northern 1410002, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

B.Y. Medimor Ltd (Owner Number: 10049471)

Owner / Operator Contact Address

Tsivonit St. 1, P.O. Box 89, Tiberias, IL-NOTA 1410002, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InMode System with Tone Applicator EmFace Device InMode Diolaze System InMode System with Fractora3D/3D-90 Applicators PathKeeper System InMode RF Multi-System InMode PLUS System Syneron CO2RE System FRACTORA InMode RF Pro System InMode System MiniFX Handpiece PMD-200 InMode Multi-system Vibrant System InMode FRF Applicator Plasma Shield DormoTech NLab INMODE WMBODY DEVICE Evolve System with the Tone Applicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-12-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-12-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-10
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-10-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-20
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
QVE	Adjunctive Pain Measurement Device For Anesthesiology	Anesthesiology	Class 2	868.2200	2023-12-11
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-12-20
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-20
QTN	Orally Ingested Transient Device For Constipation	Gastroenterology, Urology	Class 2	876.5940	2023-01-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-20
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2023-04-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-04-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-04-30
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2025-04-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-30
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-20
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-12-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2022-12-20

Official Correspondent

Marta Lino

US Agent Details

Kory Dillman Business: EVERSANA Life Science Services Email: kory.dillman@Eversana.com Phone: (816) 6457164

Related Public Records

Same Entity

B.Y. Medimor 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
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

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-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-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011782009. Last updated year: 2026. Please use registration number 3011782009 when referencing this establishment in official correspondence.