510(k) Report

Devices descending from K011092

1,127 later devices reach Candela SPTL-1E Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+5K150051ExiliteBTL Industries, Inc.20150—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K140471Pro X Otc 5La Lumiere, LLC2015107—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+5K142093V20 SystemViora, Ltd.201432—
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K131113Biophotas CellumaBiophotas, Inc.201455—
+5K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+5K121515Isolaz 2 Intense Pulsed Light SystemSolta Medical, Inc.20120—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K101415TheraclearTheravant Corporation20101—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081570DPL Therapy SystemLed Technologies, LLC200811
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+5K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+5K070690The Life VesselCottonwood Vessel Corporation20070—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K070392Mosaic Laser SystemLutronic Corporation20078—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261473ChromixTermosalud S.L.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250125LMNT O2Xplr, Ltd.20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K243488Vmat ProTermosalud20250—