510(k) Report

Devices descending from K003952

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013493Indigo Optima Laser SystemEthicon Endo-Surgery, Inc.20011—
+2K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc.20020—