510(k) Report

Devices descending from K931762

701 later devices reach Candela SPTL Pulsed Dye Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+9K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+9K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+9K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+9K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+10K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+10K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+10K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+10K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+10K244060eCO2 3DLutronic Corporation20250—
+10K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+10K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K243488Vmat ProTermosalud20250—
+10K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+10K241270BTL-754BTL Industries, Inc.20251—
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+10K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+10K230077LaserMENeauvia North America20232—
+10K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+10K221865BTL-094BTL Industries, Inc.20230—
+10K210166Omnispec ED1000Medispec, Ltd.20230—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K213674CellFX SystemPulse Biosciences, Inc.20220—
+10K222075CellFX SystemPulse Biosciences, Inc.20220—
+10K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+10K221671CellFX® SystemPulse Biosciences, Inc.20220—
+10K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+10K211639BTL-785WBTL Industries, Inc.20227—
+10K212107ReversoIntelis Instruments, Ltd.20211—
+10K212082PicoreBio-Med USA, Inc.20210—
+10K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+10K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+10K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K193426Elite iQCynosure, LLC20201—
+10K192545PotenzaJeisys Medical Incorporated202020—
+10K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K173503Pollogen Legend SystemPollogen, Ltd.20183—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+10K172096FraxisIlooda Co,., Ltd.20172—
+10K170325Secret RFIlooda Co,., Ltd.201710—
+10K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K142860Lumenis M22 SystemLumenis, Ltd.2015381
+10K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+10K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+10K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+10K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+11K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+11K253123CuRAS hybridClassys, Inc.20250—
+11K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+11K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+11K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+11K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+11K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+11K222556BTL-785XBTL Industries, Inc.20235—
+11K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+11K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+11K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+11K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K210084SilkroHironic Co., Ltd.20223—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+11K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+11K201685PotenzaJeisys Medical, Inc.20219—
+11K201735PlaDuo SystemShenB Co., Ltd.20203—
+11K202041Opera EvoQuanta System Spa20200—
+11K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—