510(k) Report

Devices descending from K963969

312 later devices reach Indigo Portable Laser System with Temperature Feedback -Model Idl 830 (Power… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K22079410PLTentech Co., Ltd.20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200616E>EyeCE-Swin20200—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—