510(k) Report

Devices descending from K974789

653 later devices reach Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L 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—
+8K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+8K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+8K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K251100Ipgtfl-02Ipg Medical Corporation20250—
+8K250504Leonardo DusterCeramoptec GmbH20250—
+8K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+8K251094Alma VeilWontech Co., Ltd.20250—
+8K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+8K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+8K242688Finiff SystemSkingrab Co., Ltd.20240—
+8K231216PotenzaJeisys Medical, Inc.20244—
+8K231287PotenzaJeisys Medical, Inc.20241—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+8K240999Legend X Applicator VOPollogen, Ltd.20241—
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K230837PlazMagikAgnes Medical Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232223PlaDuo SystemShenB Co., Ltd.20230—
+8K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+8K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+8K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183452Vbeam Prima Laser SystemCandela Corp.20191—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+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
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161825PK AIMGyrus Acmi, Inc.20162—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+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—
+9K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K252877SANDRO DualWontech Co., Ltd.20250—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+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—
+9K221770Fiber Laser 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
+9K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K163373PK AIMGyrus Acmi, Inc.20161—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+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—