510(k) Report

Devices descending from K980420

1,494 later devices reach Lightsheer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+7K151306SoleaConvergent Dental, Inc.20151—
+7K151655CO2RE SystemSyneron Medical, Ltd.20151—
+7K143554Venus Legacy CXVenus Concept, Ltd.201517—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+7K150035V10 systemViora, Ltd.201531—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K142910Legacy BXVenus Concept USA, Inc.201411—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K142093V20 SystemViora, Ltd.201432—
+7K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+7K141904Viora V-TouchViora, Ltd.20140—
+7K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K133364Picosure WorkstationCynosure, Inc.201451—
+7K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+7K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+7K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+7K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+7K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K131113Biophotas CellumaBiophotas, Inc.201455—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+7K131758Surgen UPollogen, Ltd.20135—
+7K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+7K130199Clarity LPC Laser SystemLutronic Corporation20135—
+7K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+7K120510TranscendSyneron Medical, Ltd.201318—
+7K130420SOLEAConvergent Dental, Inc.201321
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+7K122966XP200Btl Industries, Ltd.20131—
+7K123257Emvera DioluxEmvera Technologies, Inc.20123—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K122579VelashapeSyneron Medical, Ltd.20124—
+7K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+7K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K101415TheraclearTheravant Corporation20101—
+7K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+7K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K083629SmoothshapesEleme Medical, Inc.200927—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+7K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+7K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+8K261473ChromixTermosalud S.L.20260—