FDA.reportPublic FDA data

Radio-frequency skin contouring system applicator tip

Definition
A 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.
GUDID devices
86
Last updated
2026-07-30 21:31:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800020101211INTRAgen TipJeisys Medical Inc.KT-152022-03-29
08800020105028INTRAgen TipJeisys Medical Inc.KT-072016-10-31
07290016540338Viva tipVENUS CONCEPT LTDAS1100202016-09-24
00850055552012BellaFractora60 TipInbella Medical IncNG601260D2026-03-30
00850055552050BellaFractora24C TipInbella Medical IncNG604108D2026-03-30
00850055552166BellaPlus90 TipInbella Medical IncNG605906D2026-03-30
00850055552203BellaM8 B24 TipInbella Medical IncNG613054D2026-03-31
00850055552210BellaM8 B40Body TipInbella Medical IncNG613053D2026-03-31
00850055552227BellaM8 24P TipInbella Medical IncNG607563D2026-03-30
00850055552241BellaM8 24Resurf TipInbella Medical IncNG608575D2026-03-30
00850055552265BellaM8 40Body TipInbella Medical IncNG609135D2026-03-30
00850055552272BellaM8 12Prime TipInbella Medical IncNG609136D2026-03-30
00850055552579BellaM8 B24Resurf TipInbella Medical IncNG613051D2026-03-31
00850055552586BellaM8 B12Prime TipInbella Medical IncNG613052D2026-03-31
07290016633443Morpheus8 TIPINMODE M.D LTDAG607563A2023-01-23
07290019863212Morpheus8 90 TipINMODE M.D LTDAG613135A2026-04-19
08800020105042INTRAgen TipJeisys Medical Inc.KT-152016-11-18
17290016586494triFXPOLLOGEN LTDGEN 1002022-05-30
17290016586500triFXPOLLOGEN LTDGEN 36L 2022-05-30
17290016586517triFXPOLLOGEN LTDGEN 362022-05-30
17290016586524triFXPOLLOGEN LTDGEN 122022-05-30
08800016905083Wav12CLASSYS Inc.WAV122025-07-02
08800016905090Wav30CLASSYS Inc.WAV302025-07-02
08800016905106Wav50CLASSYS Inc.WAV502025-07-02
08800016905366VOLNEWMER S tipCLASSYS Inc.VLMC16002R2025-06-16
08800016905373VOLNEWMER V tipCLASSYS Inc.VLMC04002R2025-06-16
08800016905380VOLNEWMER F tipCLASSYS Inc.VLMC03002R2025-06-16
08800016905397VOLNEWMER I tipCLASSYS Inc.VLMC02502R2025-06-16
08800016905403VOLNEWMER S tip(D)CLASSYS Inc.VLMC16002D2025-06-16
08800016905410VOLNEWMER V tip(D)CLASSYS Inc.VLMC04002D2025-06-16
08800016905427VOLNEWMER F tip(D)CLASSYS Inc.VLMC03002D2025-06-16
08800016905434VOLNEWMER I tip(D)CLASSYS Inc.VLMC02502D2025-06-16
07290019863083Morpheus8 Resurfacing TIPINMODE M.D LTDAG613051A2024-08-22
07290019863090Morpheus8 Prime 12 pin TIPINMODE M.D LTDAG613052A2024-08-22
07290019863106Morpheus8 40 pin TIPINMODE M.D LTDAG613053A2024-08-22
07290019863113Morpheus8 24 pin TIPINMODE M.D LTDAG613054A2024-08-22
08800016902709VOLNEWMER S tipCLASSYS Inc.VLMC160012024-08-03
08800016902716VOLNEWMER V tipCLASSYS Inc.VLMC400012024-08-03
08800016902723VOLNEWMER F tipCLASSYS Inc.VLMC030012024-08-03
08800016902730VOLNEWMER I tipCLASSYS Inc.VLMC025012024-08-03
07290016633719FRACTORA 3D-90 TipINMODE M.D LTDAG607403A2023-04-24
07290016633627Morpheus8INMODE M.D LTDAG609135A2022-10-27
07290016633634Morpheus8INMODE M.D LTDAG609136A2022-10-27
17290016633624Morpheus8INMODE M.D LTDAG609135A_3D2022-10-27
00810096330031RADD Lumenis Be, Inc.RADD2022-09-13
00810096330055RFUTE Handpiece UpgradeLumenis Be, Inc.RFUTE Handpiece Upgrade2022-09-13
07290016586497triFXPOLLOGEN LTDGEN 1002022-05-30
07290016586503triFXPOLLOGEN LTDGEN 36L 2022-05-30
07290016586510triFXPOLLOGEN LTDGEN 362022-05-30
07290016586527triFXPOLLOGEN LTDGEN 122022-05-30
17290016586487triFXPOLLOGEN LTDH7X72022-05-30
18800020101218INTRAgen TipJeisys Medical Inc.KT-152022-03-29
07290018977026Reverso 160 Pin Tip HeadINTELIS INSTRUMENTS LTDIS-FG-000032022-01-18
07290018977033Reverso 80 Pin Tip HeadINTELIS INSTRUMENTS LTDIS-FG-000042022-01-18
07290018977040Reverso 176 Pin Tip HeadINTELIS INSTRUMENTS LTDIS-FG-000062022-01-18
07290018977057Reverso 88 Pin Tip HeadINTELIS INSTRUMENTS LTDIS-FG-000052022-01-18
07290018977064Reverso 44 Pin Tip HeadINTELIS INSTRUMENTS LTDIS-FG-000072022-01-18
07290016586121TriFractional (TF) disposable tipsPOLLOGEN LTDH7X72019-05-12
07290016586206Legend Pro TriFractional (TF) disposable tipsPOLLOGEN LTDH7X72019-05-12
07290016586213Legend Pro Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen1002019-05-12
07290016586220Legend Pro Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen36L2019-05-12
07290016586237Legend Pro Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen362019-05-12
07290016586251Legend Pro Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen122019-05-12
07290016586268Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen1002019-05-12
07290016586275Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen36L2019-05-12
07290016586053Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen362017-04-06
07290016586060Hybrid Energy (HE) disposable tipsPOLLOGEN LTDgen122017-04-06
00850608002261ThermageSOLTA MEDICALTTNS0.25NB1-2252016-09-23
00850608002278ThermageSOLTA MEDICALTTNS0.25NB1-4502016-09-23
00850608002285ThermageSOLTA MEDICALTTNS16.00E2-4002016-09-23
00850608002292ThermageSOLTA MEDICALTTNS16.00E2-5002016-09-23
00850608002308ThermageSOLTA MEDICALTTNS3.00C1-2002016-09-23
00850608002315ThermageSOLTA MEDICALTTNS3.00C1-3002016-09-23
00850608002322ThermageSOLTA MEDICALTTNS3.00C1-4002016-09-23
00850608002339ThermageSOLTA MEDICALTTNS3.00C1-6002016-09-23
00850608002346ThermageSOLTA MEDICALTTNS3.00C1-9002016-09-23
00850608002353ThermageSOLTA MEDICALTTNS3.00C2-6002016-09-23
00850608002360ThermageSOLTA MEDICALTTNS3.00C2-9002016-09-23
00850608002377ThermageSOLTA MEDICALTTNS3.00C3-4002016-09-23
00850608002384ThermageSOLTA MEDICALTTNS3.00C3-6002016-09-23