510(k) Report

Devices descending from K041879

416 later devices reach Palomar LUX1064 Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K131839DC 7Dc International, LLC20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K201773PicohiHironic Co., Ltd.20215—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K202041Opera EvoQuanta System Spa20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—