510(k) Report

Devices descending from K100384

5 later devices reach Fiberlase C02 Laser Waveguide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203799ProFlex CO2 Laser FiberInnovaquartz, LLC20211—
+1K211761UltraLase Flexible CO2 Laser WaveguideW & R Investments, LLC Dba Laser Engineering20210—
+1K130164Fiberlase Endure CO2 FiberLumenis, Ltd.201301
+1K112166Ultralase Flexible CO2 Laser WaveguideW and R Investments Dba Laser Engineering20111—
+2K243588Single Use CO2 Laser Fiber (HAF005001)Quanta System Spa20250—