FDA.reportPublic FDA data

Intradermal radio-frequency ablation system

Definition
An assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.
GUDID devices
48
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800067700385RO-25DAGNES MEDICAL CO., LTD.RO-25D2026-04-17
08800067700392RO-25S(G)AGNES MEDICAL CO., LTD.RO-25S(G)2026-04-17
08800067700408RO-25D(G)AGNES MEDICAL CO., LTD.RO-25D(G)2026-04-17
08800067700415ROS-25S(G)AGNES MEDICAL CO., LTD.ROS-25S(G)2026-04-17
08800067700422ROS-25D(G)AGNES MEDICAL CO., LTD.ROS-25D(G)2026-04-17
08800067700453AGNES ULTRAAGNES MEDICAL CO., LTD.AGNES ULTRA2026-04-16
08800067700460AN-BAGNES MEDICAL CO., LTD.AN-B2026-04-17
08800067700477AN-CAGNES MEDICAL CO., LTD.AN-C2026-04-17
08800067700484AN-EAGNES MEDICAL CO., LTD.AN-E2026-04-17
08800067700491AN-IAGNES MEDICAL CO., LTD.AN-I2026-04-17
08800067700507AN-SAGNES MEDICAL CO., LTD.AN-S2026-04-17
08800067700514AN-W3AAGNES MEDICAL CO., LTD.AN-W3A2026-04-17
08800067700521AN-F3AAGNES MEDICAL CO., LTD.AN-F3A2026-04-17
08800067700538AN-ILAGNES MEDICAL CO., LTD.AN-IL2026-04-17
08800067700545AN-SLAGNES MEDICAL CO., LTD.AN-SL2026-04-17
08800067700552AN-W3BAGNES MEDICAL CO., LTD.AN-W3B2026-04-17
08800067700576AN-F3BAGNES MEDICAL CO., LTD.AN-F3B2026-04-17
08800067700583AN-B3AAGNES MEDICAL CO., LTD.AN-B3A2026-04-17
08800067700590AN-B4AAGNES MEDICAL CO., LTD.AN-B4A2026-04-17
08800067700637AN-F1BAGNES MEDICAL CO., LTD.AN-F1B2026-04-17
08434251004173REVERSO PRO SYSTEMINDIBA SA.IDC04102025-07-31
08800016905045QUADESSY Set PackageCLASSYS Inc.QD1-M4002025-07-02
08800016905052QUADESSY Main UnitCLASSYS Inc.QD1-M4002025-07-02
G055ABMVIVR010VIVACE ULTRAAesthetics Biomedical, Inc.VERSION 1.02022-12-30
G055ABMVIVS010VIVACE ULTRAAesthetics Biomedical, Inc.VERSION 1.02022-12-30
G055ABMVIVS020VIVACE ULTRAAesthetics Biomedical, Inc.VERSION 1.02022-12-30
08800016903195Fraxis Duo 25Pin Needle TipCLASSYS Inc.MTR-AC-252024-10-30
08800016903294Secret RF Main UnitCLASSYS Inc.MTR-C12024-10-30
08800016903300Secret RF Bigger HandpieceCLASSYS Inc.MTR-C12024-10-30
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.MTR-C12024-10-30
08800016903331Secret RF Small HandpieceCLASSYS Inc.MTR-C12024-10-30
08800016903669Fraxis Duo Needle HandpieceCLASSYS Inc.FRX-C22024-10-30
08800016904628Secret DUO Set PackageCLASSYS Inc.MTR3.02024-10-30
08800016904635Secret DUO Main UnitCLASSYS Inc.MTR3.02024-10-30
08800016904642Secret DUO Bigger HandpieceCLASSYS Inc.MTR3.02024-10-30
08800016904666Secret DUO Standard HandpieceCLASSYS Inc.MTR3.02024-10-30
08800016903287Secret RF Set PackageCLASSYS Inc.MTR-C12024-10-25
08800067700002AGNESAGNES MEDICAL CO., LTD.AGNES2023-07-14
08800067700019AGNES-SAGNES MEDICAL CO., LTD.AGNES-S2023-07-14
18800067700009AGNESAGNES MEDICAL CO., LTD.AGNES2023-07-14
18800067700016AGNES-SAGNES MEDICAL CO., LTD.AGNES-S2023-07-14
08434251002636INDIBA DEEP CARE - REVERSOINDIBA SA.IDC0400USA2023-06-05
08434251002667INDIBA DEEP CARE - REVERSO - Applicator handleINDIBA SA.ACC1018USA2023-06-05
18434251002640INDIBA DEEP CARE - REVERSO - Tip 80 pinsINDIBA SA.ACC1014USA2023-06-05
18434251002657INDIBA DEEP CARE - REVERSO - Tip 160 pinsINDIBA SA.ACC1016USA2023-06-05
18434251002718INDIBA DEEP CARE - REVERSO - Tip 88 pinsINDIBA SA.ACC10152023-06-05
18434251002725INDIBA DEEP CARE - REVERSO - Tip 176 pinsINDIBA SA.ACC10172023-06-05
18434251002831INDIBA DEEP CARE - REVERSO - Tip 44 pinsINDIBA SA.ACC10132023-06-05