510(k) Report

Devices descending from K030453

524 later devices reach Cooltouch ND: Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+1K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+1K032459Profile 1320 Laser SystemSciton, Inc2004518—
+2K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+2K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+2K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+2K072344Apl Medical SystemBios S.R.L.20076—
+2K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+2K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K132754Neogen PSR SystemEnergist, Ltd.20132—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K122200A3F FrationalPollogen, Ltd.20130—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K102461FractoraInvasix, Ltd.201124—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K080374Biosyag Medical SystemBios S.R.L.20082—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K221873NeoGen PSR SystemEnergist Limited20230—
+4K22079410PLTentech Co., Ltd.20220—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K203299CellFX SystemPulse Biosciences, Inc.20214—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200616E>EyeCE-Swin20200—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193656SkyPulseFotona D.O.O.202011—
+4K180359BTL-FR2000BTL Industries, Inc.20189—
+4K180508Joule SystemSciton, Inc20183—
+4K173285Joule SystemSciton, Inc20185—
+4K172413MT ONEM&T S.R.L.20175—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160075Accent XLAlma Lasers, Inc.20160—
+4K152714Quanta ForteQuanta System Spa201513—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+4K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K131758Surgen UPollogen, Ltd.20135—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K120513Glow by EndymedEndymed Medical, Ltd.20125—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—