FDA.reportPublic FDA data

Venus Nova

Primary DI
00810060832851
Brand
Venus Nova
Company
Venus Concept Inc.
Model
FP-2001
Published
2026-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
NGXStimulator, Muscle, Powered, For Muscle Conditioning
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252845000Venus Nova (FP-2001)Venus Concept, Inc.2025-11-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060832851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060832851008100608328518100608328510810060832851

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin/body contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Regulatory Flags#

DUNS number
117333774
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060830444Venus BlissBL0000012023-06-08
00810060831359Venus Versa PROVE1024082026-04-15
00810060831632ARTAS iX SystemFP-450002018-11-12
00810060830079ARTAS SystemFP-250002023-06-08
00810060830628Venus Viva VI102402GLB2023-06-08
00810060830680Venus VersaVE1024072023-06-08
00810060830826Venus Legacy (100V)LE1000042023-06-08
00810060830833Venus Legacy (120V)LE1200042023-06-08
00810060830840Venus Legacy (240V) LE2400042023-06-08
00810060830574Venus VelocityVL0000012023-06-08
00810060830987Venus Bliss MaxBLMX00012023-06-08
00810060831250Venus AIME FP-600002023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17