510(k) Report

Devices descending from K100590

10 later devices reach Edge CO2 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+1K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+2K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+2K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+2K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+2K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+3K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+3K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+4K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+5K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—