FDA.reportPublic FDA data

Venus Versa

Primary DI
07290016540383
Brand
Venus Versa
Company
VENUS CONCEPT LTD
Model
VE102407
Device description
The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540499PackageGS11In Commercial Distribution
07290016540383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540499072900165404997290016540499
07290016540383072900165403837290016540383

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment system generatorA mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). Dedicated applicators are used to apply the different energies to the skin.

Regulatory Flags#

DUNS number
533127663
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016540260Venus Viva applicatorAS1120112018-11-18
07290016540321Venus Viva applicatorAS1100112016-09-24
07290016540390SR515 applicatorAS1200332016-09-24
07290016540420HR690 applicatorAS1200302016-09-24
07290016540437HR650XL applicatorAS1200602016-09-24
07290016540451ACDUAL applicatorAS1200582016-09-24
07290016540741Venus Viva - Diamondpolar applicatorAS1120102018-11-18
07290016540765Venus Legacy CX - LB2 applicator (new design)AS1000632018-11-18
07290016540963Venus Legacy CX - LF2 applicator (new design)AS1000752018-11-18
07290016541281BLISS SYSTEMBL0000012021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissSPK1600002021-07-14
07290016541618(MP)2 APPLICATOR BLISSAS1600432021-07-14
07290016541625BODY LASER APPLICATOR BLISSAS1600042021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissSPK1600012021-07-14
07290016541724Belt BlissAS1600272021-07-14
07290016541984Epileve Applicator Service Pack UDI LabelSPK2300102021-07-14
27290016541179HR 690XL Light Block packagePK0003242020-04-23
27290016541216HR690 Light Block packagePK0003282020-04-23
27290016541223ACDUAL Light Block packagePK0003442020-04-23
07290016540000Venus LegacyLE1200042016-09-24

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Primary DI, Brand, Company table
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B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16