510(k) Report

Devices descending from K062363

11 later devices reach BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+1K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+1K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+1K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+2K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+2K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+2K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—