510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+9K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+9K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+9K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+9K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K240897CellinewVIOL Co., Ltd.20240—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+9K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+9K233473Deka LotusEl.En S.P.A.20241—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K240313Oligio XWontech Co., Ltd.20241—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+9K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193426Elite iQCynosure, LLC20201—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K192224BTL-899Btl20198—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+9K171262TempSureCynosure, Inc.201716—
+9K172004truSculptCutera, Inc.20173—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K170908PK AIMGyrus Acmi, Inc.20170—
+9K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161038PK MorcellatorGyrus Acmi, Inc.20160—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161661Thermi RF AccessoriesThermi20163—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K160368EVO platformQuanta System Spa201636—
+9K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+9K151793InMode RF SystemInmode MD, Ltd.20161—
+9K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+9K152012EVO platformQuanta System Spa201537—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K142350PK J-HookGyrus Acmi, Inc.201511
+9K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+9K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+9K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+9K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+9K122605PKS BillGyrus Acmi, Inc.20121—
+9K102366Finess EndoscopeEntellus Medical, Inc.20110—