510(k) Report

Devices descending from K163128

16 later devices reach Epic Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+1K193656SkyPulseFotona D.O.O.202011—
+1K172771Epic Pro 940Biolase, Inc.20171—
+2K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+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—
+2K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+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—
+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—