FDA.reportPublic FDA data

Octipoar applicator for Venus Freeze

Primary DI
07290016540185
Brand
Octipoar applicator for Venus Freeze
Company
VENUS CONCEPT LTD
Model
FRWWM61
Device description
Octipolar applicator is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin I-IV.
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111670000VENUS FREEZE (MP)2 SYSTEMVenus Concept , Ltd.2012-03-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540215PackageGS11In Commercial Distribution
07290016540185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540215072900165402157290016540215
07290016540185072900165401857290016540185

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator, bipolarA bipolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes between the two tips of this device during treatment, and not through the patient to a return electrode. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533127663
Device count
1
Serial number
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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