510(k) Report

Devices descending from K081424

19 later devices reach Affirm CO2 and Affirm CO2 HP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172362Deka Smartxide TouchEl.En Electronic Engineering Spa20172—
+1K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+1K100487Equinox CO2 Laser SystemEclipsemed Global, Inc.20101—
+1K100590Edge CO2 Laser SystemJm System Co., Ltd.201010—
+2K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+2K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)El.En Electronic Engineering Spa20181—
+2K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+2K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+2K131903Equinox CO2 LaserEclipse Aesthetics, LLC20130—
+2K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+3K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+3K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+3K240497Smartxide Tetra ProEl.En S.P.A.20240—
+3K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+3K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+3K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+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—