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Venus Concept USA, Inc.

USA · Weston

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 1Class II 8Class III 0

plus 34 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 3Class III 2

16 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 1IIa 4IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States34 registration records, 22 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: Venus Concept Inc. · VENUS CONCEPT LTD. · VENUS CONCEPT INC. · VENUS CONCEPT, INC.

FDA 510(k) clearances by year

12010

12011

12012

22014

22015

22016

12017

32019

32020

12021

32022

12023

12025

FDA listed device types

showing 8 of 9

Electrosurgical, Cutting & Coagulation & Accessories 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Computer Assisted Hair Harvesting System 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Powered Microneedle Device 1Massager, Vacuum, Radio Frequency Induced Heat 1Laser For Disruption Of Adipocyte Cells For Aesthetic Use 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252845	Venus Nova (FP-2001)	2025-11-06
US	K232192	Venus Versa PRO System	2023-09-11
US	K221011	AI.ME System	2022-12-20
CA	91514	VENUS AESTHETIC RF DEVICES	Class III
CA	91520	VENUS SWAN APPLICATORS	Class II
CA	91521	VENUS SWAN ELECTRO-PADS/GLOVES	Class II

Venus Concept USA, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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