510(k) Report

Devices descending from K140336

3 later devices reach Optimus Fusion: SLT, Yag and Yag/SLT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220430CapsuloQuantel Medical20220—
+1K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20191—
+2K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20200—