510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221671CellFX® SystemPulse Biosciences, Inc.20220—
+7K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+7K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K210948Omnilux CLEARGlobalmed Technologies202139—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202172StarWalkerFotona D.O.O.20203—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+7K193426Elite iQCynosure, LLC20201—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K192430Epic 980Biolase, Inc.20195—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+7K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+7K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+7K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+7K183156V-LaserWontech Co., Ltd.20193—
+7K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+7K181518Sebacia MicroparticlesSebacia, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+7K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K161185LUCERNA Dental LaserViax Dental Lab20160—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K160368EVO platformQuanta System Spa201636—
+7K152012EVO platformQuanta System Spa201537—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142860Lumenis M22 SystemLumenis, Ltd.2015381
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+7K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+7K131839DC 7Dc International, LLC20130—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+7K130465EPIC 10SBiolase Technology, Inc.20130—
+7K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+7K111689StlaseDental Photonics, Inc.201222—
+7K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+8K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+8K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+8K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253342PICO-KSpeclipse, Inc.20251—
+8K251730LIA Console (542-7)Leadoptik, Inc.20250—
+8K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+8K253344Bellus-QSpeclipse, Inc.20250—
+8K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+8K252093Light Therapy Mask (1019055)Merchsource, LLC20250—