510(k) Report

Devices descending from K073322

22 later devices reach Fox 1-980, Fox Q-1064, Fox-Q-810 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+1K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+1K193656SkyPulseFotona D.O.O.202011—
+1K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+1K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+1K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+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—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—