510(k) Report

Devices descending from K003440

57 later devices reach Softlase - Surgical Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083142Picasso Laser SystemAmd Lasers, LLC200916—
+1K021227Softlase G2-Surgical Diode Laser SystemZap Lasers, LLC200256—
+2K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC201512—
+2K123004Mira LasersMira Lasers, LLC20130—
+2K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+2K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+2K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+2K062071Prometey, Model G1-03Spectrum International200617—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K131839DC 7Dc International, LLC20130—
+3K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+3K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+3K102639SL3Discus Dental, LLC201011
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200693K2 MobileHulaser, Inc.20202—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+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—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+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—
+6K193486Epic 980Biolase, Inc.20202—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K180044SIROLaser BlueDentsply Sirona201812—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+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—
+7K234085LUNE™ PureHygieneEnamel Pure20241—
+7K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+8K260138LUNE PureHygieneEnamel Pure20260—
+8K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—