510(k) Report

Devices descending from K062619

40 later devices reach Denlaser 800 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142223Pilot Pro Diode LaserCAO Group, Inc.20140—
+1K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+1K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+1K071896Fox 940, Model 940Valam, Inc.20080—
+1K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+2K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K193656SkyPulseFotona D.O.O.202011—
+2K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+2K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+2K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+3K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+3K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+3K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+3K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.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—
+4K200693K2 MobileHulaser, Inc.20202—
+4K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—