510(k) Report

Devices descending from K914991

352 later devices reach Versapulse (TM) Twopointone/XE Holmium Surg Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+8K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+8K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+8K251100Ipgtfl-02Ipg Medical Corporation20250—
+8K250504Leonardo DusterCeramoptec GmbH20250—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+8K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+8K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K192856MT OneM&T S.R.L.20202—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+8K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+8K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161825PK AIMGyrus Acmi, Inc.20162—
+8K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+8K152611V20 systemViora, Ltd.20164—
+8K150035V10 systemViora, Ltd.201531—
+8K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+8K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+8K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K252877SANDRO DualWontech Co., Ltd.20250—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+9K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+9K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+9K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+9K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+9K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+9K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+9K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+9K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+9K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+9K180406Ellipse YdunEllipse A/S20180—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K163373PK AIMGyrus Acmi, Inc.20161—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+9K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+9K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+9K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+9K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+9K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+9K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K242859VEGAIbramed Equipamentos Médicos20250—
+10K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+10K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+10K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+10K241656Eneka SelectifTermosalud20241—
+10K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+10K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+10K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+10K230308Alma HarmonyAlma Lasers, Inc.20232—
+10K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—