510(k) Report

Devices descending from K041011

5 later devices reach Ultralight II ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082407Modification to Ultralight II ND: Yag Laser SystemSandstone Medical Technologies, LLC20093—
+1K083272Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC20080—
+2K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC20112—
+3K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+4K233143PiXel8-RevealRohrer Aesthetics20240—