FDA.reportPublic FDA data

VENUS CONCEPT INC.

Matched from indexed company URL: VENUS CONCEPT LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065153403006515340VENUS CONCEPT INC.1N2026-01-011800 Bering Dr. San Jose CA US 95112
30087475523008747552Venus Concept USA Inc.1Y2026-01-014001 SW 47th Ave, Suite 206 Davie FL US 33314
30089153163008915316VENUS CONCEPT LTD.1N2026-01-01Hamelacha 1 St. Yokneam Illit Northern IL 2069812
30086769813008676981Venus Concept USA Inc.1Y2020-04-25419 Southfork Drive Suite 103 Lewisville TX US 75057

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1317031074285187K252845Venus Nova (FP-2001)GEI2025-11-06
1317031690393048K232192Venus Versa PRO SystemONF2023-09-11
1317031576301471K221011AI.ME SystemQAI2022-12-20
1317031839464283K220592Venus BlissMAXPBX2022-04-27
1283402001280245K220592Venus BlissMAXPBX2022-04-27
1317031403461873K201164Venus Viva MD DeviceGEI2020-06-26
1283401824001764K201164Venus Viva MD DeviceGEI2020-06-26
1283401050027677K200786Venus EpileveGEX2020-06-09
1283401332904666K191528Venus Legacy Pro DeviceGEI2019-09-06
1283401099292322K191065Venus VivaTMGEI2020-04-01
1317031142181256K190743Venus BlissPBX2019-06-25
1283401474406270K190743Venus BlissPBX2019-06-25
1283402067742539K182094Family of Venus RF Systems - HealPBX2019-02-01
1317031613059498K173358ARTAS SystemONA2018-03-16
1317031362880486K162765Venus Velocity Diode Laser SystemGEX2017-01-11
1283401782501873K162765Venus Velocity Diode Laser SystemGEX2017-01-11
1283401775155862K153717Venus Versa SystemONF2016-03-21
1317032001470538K153717Venus Versa SystemONF2016-03-21
1283401823138522K152790Venus Versa SystemONF2016-01-20
1285521508834598K150161Venus Viva SR DeviceGEI2015-05-12
1283401609637819K150161Venus Viva SR DeviceGEI2015-05-12
1283401168692046K143554Venus Legacy CXPBX2015-08-04
1285521248783229K143554Venus Legacy CXPBX2015-08-04
1317032055685822K143554Venus Legacy CXPBX2015-08-04
1283401948291327K142910Legacy BXGEI2014-12-19
1285521988538676K142910Legacy BXGEI2014-12-19
1283401835559845K111670VENUS FREEZE (MP)2 SYSTEMGEI2012-03-02
1317031420120109K103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICSONA2011-04-04
1317031018370381

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI102025-11-06
PBX82022-04-27
ONF42023-09-11
GEX32020-06-09
ONA22018-03-16
QAI12022-12-20

PMN#

GUDID#

BLISS SYSTEM - The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomenand flanks in individuals with a Body Mass Index (BMI) of 30 or less.In addition, the Venus Bliss device is intended for the treatment of the following medicalconditions; using the MP2 applicator for delivery of RF energy combined with massage andmagnetic field pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite

VENUS CONCEPT LTD

2021-07-14

BLISS SYSTEM - The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite

VENUS CONCEPT LTD

2021-07-14

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