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 intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.
GUDID devices
105
Last updated
2023-06-16 08:27:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810060830574Venus VelocityVenus Concept Inc.VL0000012023-06-08
06973512860179HuameiShandong Huamei Technology Co.,Ltd.HM-DL2202023-05-19
00860010319000Prof BeautyBEAUTEX LLCICB-EM2023-05-05
00860010319017Prof BeautyBEAUTEX LLCICB-MM2023-05-05
06976233581002Diode laser therapy systemHebei Newangel Technology Co., Ltd.ltmax2023-04-14
06974223650103VellusShenzhen Leaflife Technology Co., Ltd.HYPER HR2023-03-10
06973494934509GlobaliplBEIJING GLOBALIPL DEVELOPMENT CO., LTD.US4502023-02-01
06974223650004Leaf lifeShenzhen Leaflife Technology Co., Ltd.LM-LNIRA2022-11-05
17290110121812Diode 3D Trio 4cm HP for Soprano TitaniumALMA LASERS LTD.12022-11-06
17290110121829Soprano Titanium System 230VALMA LASERS LTD.12022-11-06
08800023200966Secret DUOILOODA.CO.,LTDSecret DUO2022-10-27
06973512860148HuameiShandong Huamei Technology Co.,Ltd.HM-DL8002022-10-21
06973512860155HuameiShandong Huamei Technology Co.,Ltd.HM-DL9002022-10-21
06973512860162HuameiShandong Huamei Technology Co.,Ltd.HM-DL6002022-10-21
00754016214134Darwin Luvo Medical Technologies Inc ESK-3272LV2022-10-14
00754016214158Darwin IPL HandpieceLuvo Medical Technologies Inc3134 A9999001LV2022-10-14
00754016214165Darwin Diode Laser HandpieceLuvo Medical Technologies Inc9300-A0000101LV2022-10-14
00754016214172RF Microneedling HandpieceLuvo Medical Technologies Inc3245-A9900201LV2022-10-14
00754016214189Darwin RF ThermalLuvo Medical Technologies Inc 7600-A992022-10-14
06970453270067Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG 20002022-08-30
06970453270074Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG 2000-B2022-08-30
06970453270081Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG 2000-C2022-08-30
06970453270098Diode Laser Therapy MachineBeijing ADSS Development Co., Ltd.FG 2000-D2022-08-30
00860007876837iProEliteMDElite Laser and Aesthetic, LLCiProElite2022-07-09
08800017500126AROMA GRANDDaeju Medi Tech Engineering1.02022-03-11
00860007876813MD Elite LaserProMDElite Laser and Aesthetic, LLCLaserPro2022-01-28
06974892091016BestviewZHENGZHOU BESTVIEW ST CO., LTDBM-1002022-01-24
08809447651316N/ALutronic CorporationAssy Foot switch2016-09-09
08809447651361N/ALutronic CorporationOperator’s Manual 2016-09-09
08809447651378N/ALutronic CorporationCooling gel2016-09-09
8809447651286ADVANTAGE POWER PLUSLutronic CorporationADVNATAGE G 110V2016-09-09
8809447651309N/ALutronic CorporationCART ASSY2016-09-09
8809447651330N/ALutronic CorporationASSY HANDPIECE 10x10mm SAHR8002016-09-09
8809447651354N/ALutronic CorporationASSY HANDPIECE 10x30mm BAHR8002016-09-09
8809447651392N/ALutronic CorporationASSY HANDPIECE 10x10mm BAHR10602016-09-09
07290016681079DioBreezeFORMATK SYSTEMS LTDFS800202021-06-25
06974223650011Leaf lifeShenzhen Leaflife Technology Co., Ltd.LM-L808A2021-06-03
00754016214028Bare 808Luvo Medical Technologies IncESM-9300LD2021-06-02
00754016214035BARE: 808 HANDPIECE Luvo Medical Technologies Inc9300-A00001012021-06-02
08437020651141elysion-proHIGH TECHNOLOGY PRODUCTS SLELYSION diode laser hair removal system2020-10-30
06973512860117HuameiShandong Huamei Technology Co.,Ltd.HM-DL1002020-10-29
06973512860124HuameiShandong Huamei Technology Co.,Ltd.HM-DL2002020-10-29
06973512860131HuameiShandong Huamei Technology Co.,Ltd.HM-DL3002020-10-29
06973537441001SUPERLASERBeijing Superlaser Technology Co., Ltd.SL-HR102020-08-08
06971679500013Diode Laser Hair Removal machineBeijing Nubway S&T Co., Ltd.QDTM-012020-07-23
06970745918103ApolomedShanghai Apolo Medical Technology Co.,LtdHS-810N2020-07-21
06970745918110ApolomedShanghai Apolo Medical Technology Co.,LtdHS-811N2020-07-21
06970745918127ApolomedShanghai Apolo Medical Technology Co.,LtdHS-812N2020-07-21
06970745918165ApolomedShanghai Apolo Medical Technology Co.,LtdHS-8162020-07-21
06970745918172ApolomedShanghai Apolo Medical Technology Co.,LtdHS-8172020-07-21
06970745918189ApolomedShanghai Apolo Medical Technology Co.,LtdHS-8182020-07-21
06970745918196ApolomedShanghai Apolo Medical Technology Co.,LtdHS-8192020-07-21
B5863159HAIR REMOVAL LASERTria Laser IncHRL 4X2020-07-13
B5863192HAIR REMOVAL LASERTria Laser IncHRL 4X2020-07-13
B5863634Hair Removal Laser PrecisisonTria Laser IncHRLp2020-07-13
B5863725HAIR REMOVAL LASERTria Laser IncHRL 4X2020-07-13
06973011720011Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdLFS-K82020-04-28
06973011720028Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdLFS-K52020-04-28
06973011720035Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdLFS-K22020-04-28
00841494100179EmergeCynosure, LLC0500-00012016-09-24
00841494100186Emerge HandpieceCynosure, LLC0520A-00012016-09-24
00841494100629EmergeCynosure, LLC0500-0001R2016-09-24
00841494100643Emerge HandpieceCynosure, LLC0520A-0001R2016-09-24
08437020651011primelase excellenceHIGH TECHNOLOGY PRODUCTS SLPRIMELASE diode laser hair removal system2020-04-09
04058784000279MeDioStarAsclepion Laser Technologies GmbHM10-0200-0002020-03-27
08809447652184N/ALutronic CorporationOperator's Goggle2018-08-06
06972590500021Lasermach PRO HandpieceWingderm Electro-Optics Ltd.WLA-012019-12-16
16972590500028Lasermach PRO HandpieceWingderm Electro-Optics Ltd.WLA-012019-12-02
B12510600TwinScan 808/755 Laser SystemGME German Medical Engineering GmbH10602019-11-29
06972590500014Lasermach Wingderm Electro-Optics Ltd.WLA-012019-11-01
06972693080031SWOTShanghai Wonderful Opto-Electrics Tech.Co.,Ltd0032019-09-28
08033945934743Quantaforte QUANTA SYSTEM SPAOAM0019042016-08-29
07290109144658LightSheer LUMENIS LTD.QUATTRO2019-04-02
17290109141609High-Speed (HS) Disposables KITLUMENIS LTD.High-Speed (HS) Disposables KIT2016-09-27
17290110121621Trio Diode Laser ModuleALMA LASERS LTD.12018-09-16
17290110121638Diode 810nm 1.2 cm2 HPALMA LASERS LTD.12018-12-13
17290110121645Diode Alex 755nmALMA LASERS LTD.12018-12-13
17290110121652Diode 810nm2 cm2 HP ALMA LASERS LTD.12018-12-13
B12510420C + B PeloGME German Medical Engineering GmbH10422018-04-16
B12510500LinScanGME German Medical Engineering GmbH10502018-11-20