510(k) Report

Devices descending from K013028

906 later devices reach Palomar SLP 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243362SmoothSkin Pure Switch (SSC1)Cyden Limited20241—
+5K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+5K241656Eneka SelectifTermosalud20241—
+5K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+5K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K240587SmoothSkin Pure Unplugged (SSB3)Cyden Limited20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233782SmoothSkin Pure Adapt (SSG3)Cyden Limited20232—
+5K232236EchoQuanta System Spa20230—
+5K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+5K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+5K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+5K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+5K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+5K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+5K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+5K193201BTL-785FBtl20208—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182604New EraStep UP Skin Laser, LLC201801
+5K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+5K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K172181micro IPLEl Global Trade, Ltd.20170—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170269Hee HR MiniOriental Inspiration Limited201713—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161089sensiLight MiniEl Global Trade, Ltd.20164—
+5K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited2016117—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K141242Glide DeviceHome Skinovations, Ltd.201419—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+5K120510TranscendSyneron Medical, Ltd.201318—
+5K122966XP200Btl Industries, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—