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Home›USA›Venus Concept , Ltd.

Venus Concept , Ltd.

USA · San Jose
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 8 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
6active ARTG entries
IIa 2IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
16registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 2Class 2b 2
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.
Same-named companies — This database also contains companies with near-identical names: Venus Concept USA, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Jose

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK252845Venus Nova (FP-2001)2025-11-06
USK232192Venus Versa PRO System2023-09-11
USK221011AI.ME System2022-12-20
CA91514VENUS AESTHETIC RF DEVICESClass III
CA91520VENUS SWAN APPLICATORSClass II
CA91521VENUS SWAN ELECTRO-PADS/GLOVESClass II

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