510(k) Report

Devices descending from K010175

88 later devices reach Microlight 830 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072551LD-I 75 and LD-I 200Meditech International, Inc.20080—
+1K063574Luminex LL Laser SystemMedical Laser Systems, Inc.20070—
+1K050668GRT Lite, Model 8-aGrt Solutions, Inc.20069—
+1K034009LAPEX 2000Meridian Co., Ltd.20051—
+1K023060Acculaser PRO4Acculaser, Inc.20042—
+1K033015Axiom Biolaser LLLT Series-3Axiom Usa., Inc.20030—
+1K030692Power Laser 90Andi Electromedical Aps200365—
+1K030226Thor Ddii 830CL3 Laser SystemThor Intl.20036—
+1K023935Trilumina Therapeutic Laser SystemTexas Applied Biomedical Services20030—
+1K021985Medx LCS Laser SeriesMedx Electronics, Inc.20029—
+1K020657Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc.200219—
+2K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..20251—
+2K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda20240—
+2K203337PainTB, PainTJPtech Co., Ltd.20220—
+2K080786ML830TPMicrolight Corporation of America20080—
+2K081141Combocare 2000Xanacare Technologies, LLC20086—
+2K070516PowerlaserPowermedic Aps200763—
+2K043353Omega Excel/XP Laser SystemAdvanced Medical Technologies, Inc.20051—
+2K024310Nma 1052 Console System with Nma 100 Laser AccessoryMedx Electronics, Inc.20030—
+3K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda20250—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+3K160246SimulCare II (TM)Xanacare Technologies, LLC20160—
+3K142025Neurolumen PN-1000Neurolumen, LLC20150—
+3K134017GigalaserPowermedic Aps20141—
+3K083822Laser TouchoneLaser Health Technologies, LLC20091—
+3K083595EzlaseBiolase Technology, Inc.200958—
+3K083202Combocare 2000Xanacare Technologies, LLC20082—
+4K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K102278Quadra Bloc Tens PlusGradient Technologies, LLC20110—
+4K100116Lasertouchone (Otc)Laser Health Technologies, LLC20100—
+5K192430Epic 980Biolase, Inc.20195—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+6K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+6K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+6K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+6K200693K2 MobileHulaser, Inc.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193486Epic 980Biolase, Inc.20202—
+6K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K160470SculpSureCynosure, Inc.201620—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+7K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K212331BodySculpRohrer Aesthetics, LLC20211—
+7K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+7K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K171111SculpsureCynosure, Inc.201710—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K192970SlimusHironic Co., Ltd.20200—
+8K171992SculpSureCynosure, Inc.20178—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K182741SculpSureCynosure20195—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—