510(k) Report

Devices descending from K011769

16 later devices reach Opus 10 (with Tooth Whitening Application), Model 2ND through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D.200913—
+1K073411LiteduoLight Instruments20081—
+1K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K193656SkyPulseFotona D.O.O.202011—
+2K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+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—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+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—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—