510(k) Report

Devices descending from K121286

31 later devices reach EPIC 10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192430Epic 980Biolase, Inc.20195—
+1K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+1K170500SIROLaser Advance+Dentsply Sirona201721—
+1K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+2K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+2K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+2K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+2K200693K2 MobileHulaser, Inc.20202—
+2K193656SkyPulseFotona D.O.O.202011—
+2K193486Epic 980Biolase, Inc.20202—
+2K180044SIROLaser BlueDentsply Sirona201812—
+3K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+3K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+3K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K234085LUNE™ PureHygieneEnamel Pure20241—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+3K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K260138LUNE PureHygieneEnamel Pure20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—