FDA.reportPublic FDA data

Radio-frequency skin contouring system

Definition
An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.
GUDID devices
108
Last updated
2025-06-11 09:52:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290016746440ST Single Use TipVIORA LTDAS470102025-06-03
08800016902945VOLNEWMERCLASSYS Inc.VM1-M1202024-08-03
07640260120044FAQ 102Foreo ABPink Ruby2024-07-18
07640260120051FAQ 103Foreo ABBlak Diamond2024-07-18
07640260120112FAQ 102Foreo ABTopaz2024-07-18
08800022305327Oligio XWONTECH CO.,LTDOligio X2024-03-21
08057168020014TriworksTRIWORKS GROUP SRLETERNA2024-02-29
08057168020090TriworksTRIWORKS GROUP SRLMedical RF2024-02-29
08052049500289OptiPLUSBIOS SRLAPMD145-1ch.US-OptiPLUS2023-11-06
08800020103536DENZA Main bodyJeisys Medical Inc.DENZA Main body2023-08-29
08800020103918DENZA B-Tip IIJeisys Medical Inc.DENZA B-Tip II2023-08-29
08800020103925DENZA B-TipJeisys Medical Inc.DENZA B-Tip2023-08-29
08800020103932DENZA F-Tip IIJeisys Medical Inc.DENZA F-Tip II2023-08-29
08800020103949DENZA F-TipJeisys Medical Inc.DENZA F-Tip2023-08-29
08800020103956DENZA I-Tip II Jeisys Medical Inc.DENZA I-Tip II 2023-08-29
08800020103963DENZA I-TipJeisys Medical Inc.DENZA I-Tip2023-08-29
08800020103970DENZA HandpieceJeisys Medical Inc.DENZA Handpiece2023-08-29
08800020103987DENZA TIP SETJeisys Medical Inc.DENZA TIP SET2023-08-29
08800020104281Density TIP SETJeisys Medical Inc.Density TIP SET2023-08-29
08800020104298Density HandpieceJeisys Medical Inc.Density Handpiece2023-08-29
08052049500272OptiPLUSBIOS SRLAPMD145-1ch.US-OptiPLUS2023-08-23
00810060830826Venus Legacy (100V)Venus Concept Inc.LE1000042023-06-08
00810060830833Venus Legacy (120V)Venus Concept Inc.LE1200042023-06-08
00810060830840Venus Legacy (240V) Venus Concept Inc.LE2400042023-06-08
08800022305310The OligioWONTECH CO.,LTDThe Oligio2023-02-17
08052049500227OptiStreamBIOS SRLAPMD145-1ch.US-Opti2022-10-04
08052049500210NUERA TIGHT 1ch Paris EditionBIOS SRLAPMD145-1ch.US-PH2022-07-06
17290110122154Opus Colibri 0.7mm Single-use Tip Set (X6)ALMA LASERS LTD.12021-11-14
17290110122161Opus Colibri 1mm Single-use Tip Set (X6)ALMA LASERS LTD.12021-11-14
17290110122178Opus Colibri 0.7mm Single-use Tip (X1)ALMA LASERS LTD.12021-11-14
17290110122185Opus Colibri 1mm Single-use Tip (X1)ALMA LASERS LTD.12021-11-14
17290110122192Glide Disposable Tip (x1)ALMA LASERS LTD.12021-11-14
17290110122208Glide Disposable Tip Set (X12)ALMA LASERS LTD.12021-11-14
08052049500135FEMINESS tipBIOS SRLAE02042021-11-02
08052049500197FEMINESSBIOS SRLAPMD145-FEM.US2021-11-02
00850017374126Sectum SystemNEAUVIA NORTH AMERICA, INC.100-13012021-09-27
00850017374133Sectum Precise (Face) ApplicatorNEAUVIA NORTH AMERICA, INC.300-13022021-09-27
00850017374140Sectum Body ApplicatorNEAUVIA NORTH AMERICA, INC.300-13012021-09-27
00850017374157Sectum Foot SwitchNEAUVIA NORTH AMERICA, INC.300-13062021-09-27
00850017374164Sectum Cable Body ApplicatorNEAUVIA NORTH AMERICA, INC.300-13082021-09-27
00850017374171Sectum Cable Precise (Face) ApplicatorNEAUVIA NORTH AMERICA, INC.300-13102021-09-27
17290110122086Opus Plasma ApplicatorALMA LASERS LTD.12021-01-25
00817495023427Applicator Frax 1940 1940 nmCandela Corporation9APP7908-CNDL2021-01-15
08052049500005THERMI 250BIOS SRLAPMD115C2016-09-29
08052049500043BIOREVITAL RF MEDBIOS SRLAPMD75CA.1202018-06-01
08052049500050NUERABIOS SRLAPMD1302018-06-06
08052049500111NUERA TIGHTBIOS SRLAPMD145-1ch.US2020-06-29
17290110121805Opus Plasma HP/ApplicatorALMA LASERS LTD.012020-02-17
17290110121768Accent Elite System 110V (Black)ALMA LASERS LTD.012019-12-31
17290110121775RF Pixel HP for Accent Elite System (110V)ALMA LASERS LTD.012019-12-31
00816995027249THERMAGESOLTA MEDICALTF-3-602019-11-08
00816995027256THERMAGESOLTA MEDICALTF-3-302019-11-08
08052049500104NUERA TIGHTBIOS SRLAPMD1402019-05-06
17290110121720Reform SystemALMA LASERS LTD.12019-05-06
17290110121706Inversa SystemALMA LASERS LTD.12019-04-08
17290110121713RF Pixel HPALMA LASERS LTD.12019-04-08
17290110121607Bipolar HPALMA LASERS LTD.12018-08-22
17290110121614Unipolar HPALMA LASERS LTD.12018-08-22
07290016541137Venus Legacy CX - LB2 applicator (new design)VENUS CONCEPT LTDAS1000632018-11-18
07290016541144Venus Legacy CX - LF2 applicator (new design)VENUS CONCEPT LTDAS1000752018-11-18
00850608002124ThermageSOLTA MEDICALTG-2B2016-09-23
00850608002131ThermageSOLTA MEDICALTC-1-42016-09-23
00850608002148ThermageSOLTA MEDICALTC-2-42016-09-23
00850608002155ThermageSOLTA MEDICALTF-2-302016-09-23
00850608002162ThermageSOLTA MEDICALTF-2-602016-09-23
00850608002179ThermageSOLTA MEDICALTH-22016-09-23
00850608002186ThermageSOLTA MEDICALTH-32016-09-23
00850608002193ThermageSOLTA MEDICALTH-42016-09-23
00850608002247ThermageSOLTA MEDICALTP-22016-09-23
00850608002889ThermageSOLTA MEDICALTH-4R2016-09-23
00850608002896ThermageSOLTA MEDICALTH-3R2016-09-23
00850608002902ThermageSOLTA MEDICALTH-2R2016-09-23
00850794007088VIVEVE Hand PieceVIVEVE, INC.VIVHP012016-09-23
00850794007101VIVEVE Hand Piece SVIVEVE, INC.VIVHP01S2016-09-23
00850794007118VIVEVE ConsoleVIVEVE, INC.VIVGE012016-09-23
00850794007132VIVEVE Console SVIVEVE, INC.VIVGE01S2016-09-23
00850794007163Universal Electrosurgical Pad (3M REF 9160) VIVEVE, INC.VIVRP022016-10-03
00850794007170VIVEVE FootswitchVIVEVE, INC.VIVFS012016-09-23
00850794007187VIVEVE Power CordVIVEVE, INC.VIVPC0X2016-10-03
00850794007194VIVEVE Return CableVIVEVE, INC.VIVRC012016-10-03