FDA.reportPublic FDA data

GENEO, GLO2FACIAL, ELITE

Primary DI
07290016586671
Brand
GENEO, GLO2FACIAL, ELITE
Company
POLLOGEN LTD
Model
RF PRO handpiece kit for GENEO X system (USA Confi
Catalog number
25000510E
Device description
"RF PRO handpiece kit (formerly branded ""TriPollar RF Applicator"" kit) for GENEO X system (formerly branded ""ELITE"") in its USA Configuration (also abbreviated 'U')."
Published
2025-02-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233766000Geneo X ElitePollogen, Ltd.2024-05-07PAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016586671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016586671072900165866717290016586671

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin contouring systemAn assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514905681
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016586572Applicator VO20900370BK2026-02-02
07290016586794MyLiftModel VXU-302 34693000BM-ML2026-02-22
07290016586817AURAModel VXU-301 34693000ND-US2026-02-22
07290016586008POLLOGEN LEGENDPOLLOGEN LEGEND+30009000U2017-04-06
07290016586565Applicator 320900360BK2026-02-02
07290016586763triLift FACEtriLift FACE300201002026-02-02
07290016586770Applicator 120900340BK2026-02-02
07290016586787Applicator 220900350BK2026-02-02
17290016586494triFXGEN 1002022-05-30
17290016586500triFXGEN 36L 2022-05-30
17290016586517triFXGEN 362022-05-30
17290016586524triFXGEN 122022-05-30
17290016586487triFXH7X730010140BK2022-05-30
07290016586534TriLiftTriLift30020000BK2022-02-13
07290016586121TriFractional (TF) disposable tipsH7X7300101402019-05-12
07290016586138Legend ProLegend Pro30020000U2019-05-12
07290016586145Legend ProLegend Pro209003002019-05-12
07290016586152Legend ProLegend Pro209003102019-05-12
07290016586169Legend ProLegend Pro209003202019-05-12
07290016586176Legend ProLegend Pro20900330U2019-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016586794MyLiftPOLLOGEN LTDPAY2026-02-22
07290016586817AURAPOLLOGEN LTDPAY2026-02-22
07640260120044FAQ 102Foreo ABPAY2024-07-18
07640260120051FAQ 103Foreo ABPAY2024-07-18
07640260120112FAQ 102Foreo ABPAY2024-07-18
07640260120037FAQ 101Foreo ABPAY2024-03-01
17290019840227Silk'nSilkn Beauty Ltd.PAY2024-01-30
17290019840234Silk'nSilkn Beauty Ltd.PAY2024-01-30
27290019840224Silk'nSILKN BEAUTY LTDPAY2024-01-30
27290019840231Silk'nSILKN BEAUTY LTDPAY2024-01-30
07290016586459Desire model UPOLLOGEN LTDPAY2023-12-15
07290016586626STOP VX2 MODEL U POLLOGEN LTDPAY2023-12-14
07290014660120NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290014660127NEWA+, Kit, US, PINKENDYMED MEDICAL LTDPAY2023-11-20
17290019840005Silk'nSilkn Beauty Ltd.PAY2023-09-14
17290019840036Silk'nSilkn Beauty Ltd.PAY2023-08-15
07290019840039Silk'nSILKN BEAUTY LTDPAY2023-08-15
07290014660113NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
17290014660110NEWA PLUS KitENDYMED MEDICAL LTDPAY2022-01-09
07290016586466STOP VX GOLD MODEL UPOLLOGEN LTDPAY2021-11-07
07290014660083NEWA KitENDYMED MEDICAL LTDPAY2021-09-23
17290112452013Silk'n HOME SKINOVATIONS LTDPAY2021-08-08
17290112451559Silk'nHOME SKINOVATIONS LTDPAY2021-08-02
07290016586442STOP VX MODEL UPOLLOGEN LTDPAY2021-06-30
07290014660021NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
17290014660028NEWA PLUS KitENDYMED MEDICAL LTDPAY2021-04-28
07290018007686STOP XPOLLOGEN LTDPAY2020-12-22
07290014660014NEWA PLUS KitENDYMED MEDICAL LTDPAY2019-11-24
07290018007303STOP XPOLLOGEN LTDPAY2019-11-07
17290112450224Silk'nHOME SKINOVATIONS LTDPAY2018-10-18