FDA.reportPublic FDA data

VENUS CONCEPT INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065153403006515340VENUS CONCEPT INC.1N2026-01-011800 Bering Dr. San Jose CA US 95112
30423515423042351542Venus Concept Inc.1N2026-01-0147 Enterprise Drive, Suite 216 Windham NH US 03087

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3520011074285187K252845Venus Nova (FP-2001)GEI2025-11-06
1317031074285187K252845Venus Nova (FP-2001)GEI2025-11-06
1317031690393048K232192Venus Versa PRO SystemONF2023-09-11
3520011690393048K232192Venus Versa PRO SystemONF2023-09-11
1317031576301471K221011AI.ME SystemQAI2022-12-20
1317031839464283K220592Venus BlissMAXPBX2022-04-27
3520011839464283K220592Venus BlissMAXPBX2022-04-27
3520011403461873K201164Venus Viva MD DeviceGEI2020-06-26
1317031403461873K201164Venus Viva MD DeviceGEI2020-06-26
3520011407605795K200786Venus EpileveGEX2020-06-09
1317031407605795K200786Venus EpileveGEX2020-06-09
3520011507893264K191065Venus VivaTMGEI2020-04-01
1317031507893264K191065Venus VivaTMGEI2020-04-01
1317031142181256K190743Venus BlissPBX2019-06-25
3520011142181256K190743Venus BlissPBX2019-06-25
1317031737556763K182094Family of Venus RF Systems - HealPBX2019-02-01
3520011737556763K182094Family of Venus RF Systems - HealPBX2019-02-01
1317031613059498K173358ARTAS SystemONA2018-03-16
1317031362880486K162765Venus Velocity Diode Laser SystemGEX2017-01-11
3520011362880486K162765Venus Velocity Diode Laser SystemGEX2017-01-11
1317032001470538K153717Venus Versa SystemONF2016-03-21
3520012001470538K153717Venus Versa SystemONF2016-03-21
3520011494955995K152790Venus Versa SystemONF2016-01-20
1317031494955995K152790Venus Versa SystemONF2016-01-20
3520011075113462K150161Venus Viva SR DeviceGEI2015-05-12
1317031075113462K150161Venus Viva SR DeviceGEI2015-05-12
1317032055685822K143554Venus Legacy CXPBX2015-08-04
3520012055685822K143554Venus Legacy CXPBX2015-08-04
3520011765361844K142910Legacy BXGEI2014-12-19
1317031765361844K142910Legacy BXGEI2014-12-19
3520011286496842K111670VENUS FREEZE (MP)2 SYSTEMGEI2012-03-02
1317031286496842K111670VENUS 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
GEI142025-11-06
PBX112022-04-27
ONF82023-09-11
GEX52020-06-09
ONA22018-03-16
QAI12022-12-20

GUDID#