Data / Medical devices / United States / Venus Concept Inc.

Venus Concept Inc.: FDA-registered device maker in San Jose, CA, United States, 18 510(k) clearances

Name: Venus Concept Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Venus Concept Inc. is registered with the FDA (registration 3006515340) in San Jose, CA, United States. It lists 9 device types. The FDA files 18 510(k) clearances under its listings, the newest dated November 6, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006515340
Address: 1800 Bering Dr., San Jose, CA, United States, 95112
Owner or operator: Venus Concept Inc. (10037692)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: August 8, 2011
Registered through: 2026
Brand names listed: AIME System, ARTAS Patient Chair, ARTAS System, ARTAS iX, Bliss Max, Venus Bliss, Venus Epileve, Venus Freeze (MP)2 and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Surgical, Non-Electrical	FZK	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Computer Assisted Hair Harvesting System	ONA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Laser For Disruption Of Adipocyte Cells For Aesthetic Use	PKT	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 6, 2025	K252845	Venus Nova (FP-2001)	GEI	Substantially Equivalent	Venus Concept, Inc.	accessdata.fda.gov
September 11, 2023	K232192	Venus Versa PRO System	ONF	Substantially Equivalent	Venus Concept, Inc.	accessdata.fda.gov
December 20, 2022	K221011	AI.ME System	QAI	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
April 27, 2022	K220592	Venus BlissMAX	PBX	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
June 26, 2020	K201164	Venus Viva MD Device	GEI	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
June 9, 2020	K200786	Venus Epileve	GEX	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
April 1, 2020	K191065	Venus VivaTM	GEI	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
June 25, 2019	K190743	Venus Bliss	PBX	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
February 1, 2019	K182094	Family of Venus RF Systems - Heal	PBX	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
March 16, 2018	K173358	ARTAS System	ONA	Substantially Equivalent	Restoration Robotics, Inc.	accessdata.fda.gov
January 11, 2017	K162765	Venus Velocity Diode Laser System	GEX	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
March 21, 2016	K153717	Venus Versa System	ONF	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
January 20, 2016	K152790	Venus Versa System	ONF	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
August 4, 2015	K143554	Venus Legacy CX	PBX	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
May 12, 2015	K150161	Venus Viva SR Device	GEI	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
December 19, 2014	K142910	Legacy BX	GEI	Substantially Equivalent	Venus Concept USA, Inc.	accessdata.fda.gov
March 2, 2012	K111670	VENUS FREEZE (MP)2 SYSTEM	GEI	Substantially Equivalent	Venus Concept , Ltd.	accessdata.fda.gov
April 4, 2011	K103428	THE ARTAS SYSTEM FROM RESTORATION ROBOTICS	ONA	Substantially Equivalent	Restoration Robotics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 13, 2013	66558	Class II	Terminated	Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. P	Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.	accessdata.fda.gov

Compare with other makers

Updated November 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.