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
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+8K151629Guardian 1000Quanta System Spa20150—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K121286EPIC 10Biolase Technology, Inc.201231—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+8K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+8K094049Stlase Diode LaserDental Photonics, Inc.201023—
+8K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+8K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+9K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+9K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+9K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+9K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+9K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K210084SilkroHironic Co., Ltd.20223—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K202041Opera EvoQuanta System Spa20200—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K192430Epic 980Biolase, Inc.20195—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K170500SIROLaser Advance+Dentsply Sirona201721—
+9K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+9K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+9K111689StlaseDental Photonics, Inc.201222—
+10K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+10K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—