510(k) Report

Devices descending from K011197

762 later devices reach Dermaclear UV-B Phototherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K22079410PLTentech Co., Ltd.20220—
+5K212790XLase PlusBiotec Italia, Srl20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203728DarwinLuvo Medical Technologies, Inc.20211—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200616E>EyeCE-Swin20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+5K193656SkyPulseFotona D.O.O.202011—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K180508Joule SystemSciton, Inc20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172413MT ONEM&T S.R.L.20175—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131758Surgen UPollogen, Ltd.20135—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250165PastelleWontech Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K193201BTL-785FBtl20208—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—