510(k) Report

Devices descending from K933362

1,220 later devices reach Sharplan CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+8K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K231948MediyagMedicreations, LLC20240—
+8K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+8K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+8K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+8K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+8K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+8K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+8K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+8K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K221873NeoGen PSR SystemEnergist Limited20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K22079410PLTentech Co., Ltd.20220—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K213612Sylfirm XVIOL Co., Ltd.20221—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K211562Virtue RFShenB Co., Ltd.20212—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K203299CellFX SystemPulse Biosciences, Inc.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K200616E>EyeCE-Swin20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K192728AgnesAgnes Medical Co., Ltd.20196—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+8K182365TempSure SystemCynosure, Inc.201815—
+8K180338CellulizeWard Photonics, LLC20182—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K180508Joule SystemSciton, Inc20183—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K172413MT ONEM&T S.R.L.20175—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+8K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K163415SlimShape SystemSyneron Medical, Ltd.201714—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—