510(k) Report

Devices descending from K080463

15 later devices reach Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+1K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.20250—
+2K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+2K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+2K151655CO2RE SystemSyneron Medical, Ltd.20151—
+2K141658Light ScalpelLightscalpel, LLC20142—
+3K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+3K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+3K222221Deka HelixEl.En Electronic Engineering Spa20231—
+3K173827LightScalpelLightscalpel, LLC20180—
+3K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K252561BTL-754FFBTL Industries, Inc.20260—