510(k) Report

Devices descending from K000317

240 later devices reach Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K152611V20 systemViora, Ltd.20164—
+6K150035V10 systemViora, Ltd.201531—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K242349FoLixLumenis Be, Ltd.20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K231948MediyagMedicreations, LLC20240—
+8K241656Eneka SelectifTermosalud20241—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230308Alma HarmonyAlma Lasers, Inc.20232—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K181272Picocare FamilyWontech Co., Ltd.20188—