VENUS CONCEPT INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3006515340

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006515340
FEI Number
3006515340
Entity Name
VENUS CONCEPT INC.
City/State/Country
San Jose, CA, US
Establishment Address
1800 Bering Dr., San Jose, CA 95112, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Venus Concept Inc. (Owner Number: 10037692)
Owner / Operator Contact Address
1800 Bering Drive, San Jose, CA 95112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K103428
PMA Number
N/A

All Registered Proprietary Names

ARTAS Patient Chair Venus Versa Venus Nova Venus Legacy Venus Viva AIME System Bliss Max Venus Bliss ARTAS iX ARTAS System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZK Chair, Surgical, Non-Electrical General, Plastic Surgery Class 1 878.4950 2018-02-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-01
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2021-09-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-11-17
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2025-11-17
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-11-17
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-03-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-09-01
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2023-02-07
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2023-04-20
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery Class 2 878.5400 2023-04-20
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-04-20
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2021-09-01
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery Class 2 878.5400 2021-09-01
ONA Computer Assisted Hair Harvesting System Neurology Class 2 882.4560 2018-11-09
ONA Computer Assisted Hair Harvesting System Neurology Class 2 882.4560 2011-08-08

Official Correspondent

Danielle Fulk

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Venus Concept Inc.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006515340. Last updated year: 2026. Please use registration number 3006515340 when referencing this establishment in official correspondence.
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