FDA.reportPublic FDA data

POLLOGEN LEGEND

Primary DI
07290016586039
Brand
POLLOGEN LEGEND
Company
POLLOGEN LTD
Model
POLLOGEN LEGEND+
Catalog number
21400370
Device description
Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.3 is indicated for the treatment of very small facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.
Published
2017-04-06
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
K111026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111026000APOLLOPollogen, Ltd.2011-11-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016586039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016586039072900165860397290016586039

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
514905681
Device count
1
DM exempt
true
Serial number
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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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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