510(k) Report

Devices descending from K120231

4 later devices reach Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+2K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+2K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+2K202041Opera EvoQuanta System Spa20200—