Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008915316

FEI Number

3008915316

Entity Name

VENUS CONCEPT LTD.

City/State/Country

Yokneam Illit Northern, IL

Establishment Address

Hamelacha 1 St., Yokneam Illit Northern 2069812, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Venus Concept Ltd. (Owner Number: 10036213)

Owner / Operator Contact Address

Hamelacha 1 St., Yokneam Illit, IL-Z 2069812, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191528

PMA Number

N/A

All Registered Proprietary Names

Legacy CX, Venus Legacy CX Venus Heal Venus Bliss Venus BlissMAX Venus Viva Venus Viva SR Device Venus Viva Venus Viva MD Venus Versa Legacy BX, Venus Legacy BX Venus Versa Venus Legacy Pro Venus Legacy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2015-09-03
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-02-04
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-06-26
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2019-06-26
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	General, Plastic Surgery	Class 2	878.5400	2022-12-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-12-01
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-04-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-08-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-10
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2016-01-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-09-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-03-30
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2016-03-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-11-04
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2019-11-04

Official Correspondent

Danielle Fulk

US Agent Details

Slava Shubnikov Business: Venus Concept USA Inc Email: slava@venusconcept.com Phone: (888) 9070115

Related Public Records

Same Entity

Venus Concept 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
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

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

Similar Registrations

Registration Number	Establishment Name	Location
3044778118	S&M MEDICAL INC.	Gwangju, KR
3007491751	UNIBELL SRL	Calco Lecco, IT
3026400760	TERMOSALUD S.L.	Gijon Asturias, ES
1725006	CAO GROUP, INC.	W Jordan, UT, US
3010836847	INDIBA	Sant Quirze del Valles Barcelona, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008915316. Last updated year: 2026. Please use registration number 3008915316 when referencing this establishment in official correspondence.