510(k) Report

Devices descending from K082707

59 later devices reach Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193656SkyPulseFotona D.O.O.202011—
+1K083595EzlaseBiolase Technology, Inc.200958—
+2K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+2K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+2K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+2K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+2K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+3K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+3K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+3K192430Epic 980Biolase, Inc.20195—
+3K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+3K170500SIROLaser Advance+Dentsply Sirona201721—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+3K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+3K150724SculpSureCynosure, Inc.201521—
+3K150230SculpSureCynosure, Inc.201521—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K200693K2 MobileHulaser, Inc.20202—
+4K193486Epic 980Biolase, Inc.20202—
+4K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K160470SculpSureCynosure, Inc.201620—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+5K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+5K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+5K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+5K211681EONDominion Aesthetic Technologies, Inc.20221—
+5K212331BodySculpRohrer Aesthetics, LLC20211—
+5K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K171111SculpsureCynosure, Inc.201710—
+6K260138LUNE PureHygieneEnamel Pure20260—
+6K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K222226EONDominion Aesthetic Technologies, Inc.20230—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K192970SlimusHironic Co., Ltd.20200—
+6K171992SculpSureCynosure, Inc.20178—
+7K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+7K231971Deka Physiq 360El.En S.P.A.20230—
+7K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+7K182741SculpSureCynosure20195—
+8K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+8K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—