FDA.reportPublic FDA data

Dermatological diode laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.
GUDID devices
80
Last updated
2026-06-05 06:05:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.V192026-05-27
06970453270173Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-B2025-10-30
06970453270180Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-B pro2025-10-30
06970453270197Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-D+ 2025-10-30
06970453270203Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-D+pro 2025-10-30
06970453270210Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-E2025-10-30
06970453270647Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG2000-D+ 2025-10-30
06972978060116Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060123Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060130Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060147Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060154Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060161Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060178Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06972978060185Lasermach Wingderm Electro-Optics Ltd.WLA-022026-04-20
06978716980012Diode Laser Hair Removal MachineSanhe Meditech Co.LtdGLD012026-05-13
08809447651279ADVANTAGE POWER PLUSLutronic CorporationADVNATAGE G 110V2016-09-09
08809447651293N/ALutronic CorporationCART ASSY2016-09-09
08809447651323N/ALutronic CorporationASSY HANDPIECE 10x10mm SAHR8002016-09-09
08809447651347N/ALutronic CorporationASSY HANDPIECE 10x30mm BAHR8002016-09-09
08809447651385N/ALutronic CorporationASSY HANDPIECE 10x10mm BAHR10602016-09-09
17290117770730High-Speed (HS) Disposables KITLUMENIS BE LTDHigh-Speed (HS) Disposables KIT2023-08-10
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.8082026-03-23
00860009525122MediDiodeMEDICREATIONS LLC2.02026-02-11
08057017760962LUVOEL.EN. SPAM117H12025-11-24
04058784001542OMNIAsclepion Laser Technologies GmbHO10-0200-0002025-08-08
06971679500624NubwayBeijing Nubway S&T Co., Ltd.QDTM-022025-05-17
08057622080004MTONE EVOM & T SRLMtone evo2025-04-15
08057622080011MTONE EVOM & T SRLMtone evo lite2025-04-15
08057622080028MT ONEM & T SRLMt one2025-04-15
08057622080035MT ONEM & T SRLMT ONE/D2025-04-15
08057622080042MT ONE DIAMONDM & T SRLMT ONE DIAMOND2025-04-15
G7433724HAIR REMOVAL LASERTria Laser IncHRL 4X2025-03-07
08800016904659Secret DUO Laser HandpieceCLASSYS Inc.MTR3.02024-10-30
06928258000846GSDShenzhen GSD Tech Co., Ltd.GP900A82024-09-30
06928258000853GSDShenzhen GSD Tech Co., Ltd.GP900Q82024-09-30
06928258000907GSDShenzhen GSD Tech Co., Ltd.GP900A2024-09-30
06928258000914GSDShenzhen GSD Tech Co., Ltd.GP900Q2024-09-30
06977620360002ZHEONEHebei Zhemai Technology Co., Ltd. FD-L012024-09-19
06976812430127Artemis Diode Laser SystemRhein Laser Technologies Co.,Ltd.RL-S20S-TWC2024-09-14
06976812430134Artemis Diode Laser SystemRhein Laser Technologies Co.,Ltd.RL-S20S-810B2024-09-14
06976812430141Artemis Diode Laser SystemRhein Laser Technologies Co.,Ltd.RL-S20S-7552024-09-14
06976812430110TitanPico Laser WorkstationRhein Laser Technologies Co.,Ltd.PICO-4502024-09-12
06940481500139DermRays ReviveWuhan Lotuxs Technology Co.,Ltd.LHR-S5-10642024-08-29
06974077940009MLKJWeifang Mingliang Electronics Co., Ltd.V162024-07-23
07898672790311Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAHakon2024-07-22
07898672790557Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAHakon Smart2024-07-22
08059173396375EchoQUANTA SYSTEM SPAEcho2024-06-21
06973511890009SANOBeijing Sano Lasers S&T Development Co., Ltd.P-808, P-808L, P-808S, P-808W2024-05-15
06973663791049Diode Laser Therapy SystemsBEIJING UNT TECHNOLOGY CO.,LTDAlpha2024-04-25
08057017760856NIRVANAEL.EN. SPAM117H12024-04-18
17290110123526Diode 755nm Alex Applicator for Soprano Titanium (Black)ALMA LASERS LTD.12024-03-17
08437019546014Leaseir Technologies SLULEASEIR TECHNOLOGIES SOCIEDAD LIMITADA.Leaseir MHR Xcell2024-02-21
00860010800508MIRIAAvava, Inc.N/A2023-12-20
00860010800515MIRIAAvava, Inc.N/A2023-12-20
08800023200942Secret DUO Main UnitILOODA.CO.,LTDSecret DUO2023-08-30
08800023200959Secret DUO Standard HandpieceILOODA.CO.,LTDSecret DUO2023-08-30
08800023201239Secret DUO Bigger HandpieceILOODA.CO.,LTDSecret DUO2023-08-30
08800023201390Secret DUO Laser HandpieceILOODA.CO.,LTDSecret DUO2023-08-30
06971513121046KESBeijing KES Biology Technology Co.,Ltd.MED-8082023-08-10
07290117770030LightSheer® Quattro™LUMENIS BE LTDLightSheer® Quattro™2023-08-10
07290117770061LightSheer® HS 805 HandpieceLUMENIS BE LTDLightSheer® HS 805 Handpiece2023-08-10
07290117770078LightSheer® ET 805 HandpieceLUMENIS BE LTDLightSheer® ET 805 Handpiece2023-08-10
07290117770085LightSheer® XC 805 HandpieceLUMENIS BE LTDLightSheer® XC 805 Handpiece2023-08-10
07290117770092LightSheer® ET 1060 HandpieceLUMENIS BE LTDLightSheer® ET 1060 Handpiece2023-08-10
07290117770108LightSheer® HS 1060 HandpieceLUMENIS BE LTDLightSheer® HS 1060 Handpiece2023-08-10
07290117770733High-Speed (HS) Disposables KITLUMENIS BE LTDHigh-Speed (HS) Disposables KIT2023-08-10
07290117770115LightSheer® XC 1060 HandpieceLUMENIS BE LTDLightSheer® XC 1060 Handpiece2023-08-08
07290117770122LightSheer® Quattro™ Light LUMENIS BE LTDLightSheer® QuattroTM Light2023-08-08
07290117771037LightSheer Duet, with ET and HS HandpiecesLUMENIS BE LTDNA2023-06-22
07290117771068LightSheer Desire LightLUMENIS BE LTDNA2023-06-22
07290117771075LightSheer DesireLUMENIS BE LTDNA2023-06-22
07290117771082LightSheer Desire, BasicLUMENIS BE LTDNA2023-06-22
07290016814361PURE Laser, SystemENDYMED MEDICAL LTDPURE Laser2023-06-19
06974851081010BVLASERNanjing Bestview Laser S&T Co.,Ltd.BM-1002023-06-12
06972978060017Lasermach PROWingderm Electro-Optics Ltd.WLA-012020-11-16
06972978060024Lasermach PRO Handpiece Wingderm Electro-Optics Ltd.WLA-012020-11-16
08800023200218VIKINI Main UnitILOODA.CO.,LTDDET Main Unit2018-01-15
08800023200225VIKINI Laser H/PILOODA.CO.,LTDDET Laser H/P2018-01-17
08809447652191N/ALutronic CorporationMetal Goggle (for patient)2018-08-06