FDA.reportPublic FDA data

Radio-frequency skin surface treatment system

Definition
An 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.
GUDID devices
35
Last updated
2026-07-28 06:05:35

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290016540161Venus Freeze MP2VENUS CONCEPT LTDFRWMUS250025E2016-09-24
07290016540192Venus Freeze kitVENUS CONCEPT LTDFRFLEUWU802016-09-24
07290016540260Venus Viva applicatorVENUS CONCEPT LTDAS1120112018-11-18
07290016540277Venus Viva kit packageVENUS CONCEPT LTDPK0000902018-11-18
07290016540307Venus VivaVENUS CONCEPT LTDVI1024022016-09-24
07290016540345Venus Viva kitVENUS CONCEPT LTDPK0000442016-09-24
07290016540741Venus Viva - Diamondpolar applicatorVENUS CONCEPT LTDAS1120102018-11-18
07290016541052Venus Vila GLB systemVENUS CONCEPT LTDVI102402GLB2018-11-18
07290016541069Venus Viva GLB applicatorVENUS CONCEPT LTDAS110011GLB2018-11-18
07290016541076Venus Viva GLB Diamondpolar applicatorVENUS CONCEPT LTDAS110009GLB2018-11-18
07290016541083Venus Viva GLB packageVENUS CONCEPT LTDPK0001302018-11-18
07290016541090Venus Viva GLB applicator spare parts packageVENUS CONCEPT LTDPK0001312018-11-18
07290016541106Venus Viva GLB Diamondpolar applicator spare parts packageVENUS CONCEPT LTDPK0001322018-11-18
07290016541540Venus Viva system - NikaoVENUS CONCEPT LTDVI102402NI2018-11-18
00884785000017NutritoneIsomers Laboratories IncT3002020-10-05
05060445341309Sensifirm - bronzeEL GLOBAL TRADE LTDCEL100US04SNS2020-11-05
08809447650883INFINILutronic CorporationINFINI MFR G U110V2016-09-09
08809447650982N/ALutronic CorporationMFR Handpiece 2016-09-09
08809447651019N/ALutronic CorporationHandpiece cradle2016-09-09
08809447651781N/ALutronic CorporationTIP A-49 1 ea2016-11-18
08809447652207N/ALutronic CorporationAC POWER CABLE2018-12-13
08809447652214N/ALutronic CorporationHandpiece cradle2018-12-13
08809447652238LUTRONIC GENIUSLutronic CorporationGENIUS G U110V2018-12-13
08809447652252N/ALutronic CorporationLutronic Genius Operator's Manual USA2018-12-13
08809447652276N/ALutronic CorporationG49D TIP(200, 0.5) Lutronic GENIUS 2018-12-13
08809447652283N/ALutronic CorporationHANDPIECE_LUTRONIC GENIUS2018-12-13
08809447652290N/ALutronic CorporationHandpiece Holder2018-12-13
08809447652375INFINILutronic Corporation49 pin Tip (Standard) 1 ea2019-01-15
08809447652399INFINILutronic Corporation16 pin Tip (Optional) 1 ea2019-01-15
08809447652405LUTRONIC GENIUSLutronic CorporationLutronic Genius Operator's Manual Korea2019-01-22
08809447653228LUTRONIC GENIUSLutronic CorporationM49D TIP Lutronic GENIUS2020-07-09
08809447653242LUTRONIC GENIUSLutronic CorporationP14D TIP Lutronic GENIUS2020-07-09
08809447653266LUTRONIC GENIUSLutronic CorporationP16D TIP Lutronic GENIUS2020-07-09
17290015763858Silk'nHOME SKINOVATIONS LTDTitan2017-05-09
08800023200171Secret RF Main UnitILOODA.CO.,LTDMTR 2.0 Main Unit2017-08-11