510(k) Report

Devices descending from K982940

1,526 later devices reach Lightsheer Pulsed Diode Array Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K150051ExiliteBTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K141904Viora V-TouchViora, Ltd.20140—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+6K131758Surgen UPollogen, Ltd.20135—
+6K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+6K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+6K122966XP200Btl Industries, Ltd.20131—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K123257Emvera DioluxEmvera Technologies, Inc.20123—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K122579VelashapeSyneron Medical, Ltd.20124—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K101415TheraclearTheravant Corporation20101—
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+6K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083629SmoothshapesEleme Medical, Inc.200927—
+6K081570DPL Therapy SystemLed Technologies, LLC200811
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+6K070690The Life VesselCottonwood Vessel Corporation20070—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261473ChromixTermosalud S.L.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+7K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+7K243854Contour Light (CL-100)Contour Research, LLC20261—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252877SANDRO DualWontech Co., Ltd.20250—
+7K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal…Miley Technology (Hebei) Co., Ltd.20250—
+7K251327XERFLutronic Corporation202501
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd.20251—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Bestway Plastic and Metal Products, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—