510(k) Report

Devices descending from K023967

554 later devices reach Palomar Q-Yag ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+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—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180406Ellipse YdunEllipse A/S20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202503ChromeQuanta System Spa202012—
+9K202041Opera EvoQuanta System Spa20200—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—