510(k) Report

Devices descending from K083069

36 later devices reach Ezlase 10W through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193656SkyPulseFotona D.O.O.202011—
+1K121286EPIC 10Biolase Technology, Inc.201231—
+1K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+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—
+2K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K200693K2 MobileHulaser, Inc.20202—
+2K192430Epic 980Biolase, Inc.20195—
+2K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+2K170500SIROLaser Advance+Dentsply Sirona201721—
+2K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+2K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+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—
+3K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+3K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+3K193486Epic 980Biolase, Inc.20202—
+3K180044SIROLaser BlueDentsply Sirona201812—
+3K123004Mira LasersMira Lasers, LLC20130—
+4K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+4K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+4K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+4K234085LUNE™ PureHygieneEnamel Pure20241—
+4K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+5K260138LUNE PureHygieneEnamel Pure20260—
+5K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+6K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—