510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+4K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+4K173759Thermage CPT System and AccessoriesSolta Medical201821
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K171702Exciplex308nmClarteis20175—
+4K170758Thermage FLX System and AccessoriesSolta Medical201713—
+4K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K161669Waterlase ExpressBiolase, Inc.201621—
+4K152737Lite TouchFocus Medical, LLC20160—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+4K142910Legacy BXVenus Concept USA, Inc.201411—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+4K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+4K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+4K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K131758Surgen UPollogen, Ltd.20135—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+4K120510TranscendSyneron Medical, Ltd.201318—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K122966XP200Btl Industries, Ltd.20131—
+4K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+4K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+4K122237Biophotas LifelightBiophotas, Inc.201371—
+4K123257Emvera DioluxEmvera Technologies, Inc.20123—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K111286Quasar CalypsoSilver Bay, LLC201276—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+4K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+4K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—