FDA.reportPublic FDA data

Venus Viva applicator

Primary DI
07290016540703
Brand
Venus Viva applicator
Company
VENUS CONCEPT LTD
Model
AS112011
Published
2018-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150161000Venus Viva SR DeviceVenus Concept , Ltd.2015-05-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540703PackageGS11In Commercial Distribution
07290016540260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540703072900165407037290016540703
07290016540260072900165402607290016540260

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin?s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533127663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016541281BLISS SYSTEMBL0000012021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissSPK1600002021-07-14
07290016541625BODY LASER APPLICATOR BLISSAS1600042021-07-14
07290016541724Belt BlissAS1600272021-07-14
07290016540765Venus Legacy CX - LB2 applicator (new design)AS1000632018-11-18
07290016540963Venus Legacy CX - LF2 applicator (new design)AS1000752018-11-18
07290016541618(MP)2 APPLICATOR BLISSAS1600432021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissSPK1600012021-07-14
07290016540000Venus LegacyLE1200042016-09-24
07290016540055Venus Legacy kitPK0000082016-09-24
07290016540079LB1 + LF1 kitPK0000412016-09-24
07290016540086Venus Legacy - 110V SystemLE1000042018-11-18
07290016540109Venus Legacy LE2400042016-09-24
07290016540116Venus Legacy kitPK0000022016-09-24
07290016541472Venus Legacy 240V - NikaoAS100005NI2018-11-18
07290016541533Venus Legacy 110V - NikaoLE120004NI2018-11-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14