510(k) Report

Devices descending from K103501

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

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