510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260632Laser Thermal Therapy KitElesta S.P.A20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+8K250852CoolfaseAsterasys Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251327XERFLutronic Corporation202501
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K242241SunnyShenB Co., Ltd.20250—
+8K250281Deka LotusEl.En S.P.A.20250—
+8K243488Vmat ProTermosalud20250—
+8K241270BTL-754BTL Industries, Inc.20251—
+8K240311JETT Medical IICompex, Spol, S.R.O.20250—
+8K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K242710Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro…Shenzhen Jianchao Intelligent Technology Co., Ltd.20243—
+8K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+8K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+8K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+8K240248Volnewmer™Classys, Inc.20241—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K23299210THERMATentech, Inc.20230—
+8K233237xeo+ FamilyCutera, Inc.20230—
+8K232939IPL Hair Removal DeviceShenzhen Borria Technology Co., Ltd.20234—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232056IPL Hair Removal Device, Model (s): PB1, PB2, PB3, PB4, TM002Dongguan Lide Electric Appliance Co., Ltd.20230—
+8K232274IPL hair removal deviceLumenessa Corp20230—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K231146AliTightAlic Iotech, LLC20230—
+8K231717IPL Home Use Hair Removal Device, Model (s): JD-TM002, JD-TM003, JD-TM012, JD-TM016…Foshan Jindi Electric Appliance Co., Ltd.202311—
+8K230663DensityJeisys Medical, Inc.20232—
+8K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230077LaserMENeauvia North America20232—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd.202311—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230122IPL Hair Removal Device, Model (s): UI04 SD, UI04 DGShenzhen Ulike Smart Electronics Co., Ltd.202317—
+8K223618IPL Hair Removal Device, Model (s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06…Shenzhen Ulike Smart Electronics Co., Ltd.20236—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223524IPL Hair Removal, Model (s): SB01, SB01A, SB01B, SB01C, SN02, SN03Morlaser Shenzhen Co., Ltd.20230—
+8K223680Eneka ProTermosalud20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K222701MANTA LaserSqualus Med, Ltd.20222—
+8K221643Hair Removal Device (Model: IPL-D26, IPL-D19)Shenzhen Desida Technology Co., Ltd.20220—
+8K222537IPL Hair Removal Device, Model (s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited202211—
+8K221989The OligioWontech Co., Ltd.20222—
+8K222369PURE LaserEndymed Medical, Ltd.20220—
+8K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd.20221—
+8K221761SoleaConvergent Dental, Inc.202201
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+8K221002IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co., Ltd.202225—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K213594Echolaser X4Elesta S.P.A20221—
+8K220645Hand-held IPL device (JOVS Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202219—
+8K214113Hand-held IPL device (JOVS Graphene Hair Removal Device)Shenzhen Qianyu Technology Co., Ltd.202222—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K213428EdgeProBiolase, Inc.20210—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K211185IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20218—
+8K212697Leaf SmoothShenzhen Leaflife Technology Co., Ltd.20210—
+8K211444CellFX SystemPulse Biosciences, Inc.20213—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—