510(k) Report

Devices descending from K013493

1 later device reach Indigo Optima Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc.20020—