510(k) Report

Devices descending from K003953

4 later devices reach Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc.20071—
+1K013493Indigo Optima Laser SystemEthicon Endo-Surgery, Inc.20011—
+2K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+2K023182Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-BPH, Optima Bare-Tip…Ethicon Endo-Surgery, Inc.20020—