FDA.reportPublic FDA data

Hybrid Energy (HE) disposable tips

Primary DI
07290016586268
Brand
Hybrid Energy (HE) disposable tips
Company
POLLOGEN LTD
Model
gen100
Catalog number
30010150
Device description
Hybrid Energy (HE) disposable tips gen100
Published
2019-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K173503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173503000Pollogen Legend SystemPollogen, Ltd.2018-06-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016586268PrimaryGS10
17290016586265Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016586268072900165862687290016586268
1729001658626517290016586265

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring system applicator tipA removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514905681
Device count
5
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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

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Primary DI, Brand, Company table
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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