FDA.reportPublic FDA data

OPTILIFT FRACTIONAL

Primary DI
07290019147657
Brand
OPTILIFT FRACTIONAL
Company
POLLOGEN LTD
Model
OPTILIFT FRACTIONAL
Catalog number
35000510
Device description
The application of radiofrequency and dynamic muscle stimulation or activation (DMSt or DMA)
Published
2025-10-28
Public version status
New
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290019147668PackageGS11In Commercial Distribution
07290019147657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001914766827290019147668
07290019147657072900191476577290019147657

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment system applicatorA handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device.

Regulatory Flags#

DUNS number
514905681
Device count
1
DM exempt
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
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18