510(k) Report

Devices descending from K990851

6 later devices reach Indigo Laseroptic Treatment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022655Trimedyne Side Firing Needle with Vent SheathTrimedyne, Inc.20023—
+1K013493Indigo Optima Laser SystemEthicon Endo-Surgery, Inc.20011—
+2K050412VapormaxTrimedyne, Inc.20052—
+2K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc.20020—
+3K053457Vapormax IITrimedyne, Inc.20051—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—