510(k) Report

Devices descending from K052675

3 later devices reach Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact…Synergeyes, Inc.20141—
+1K060102Synergeyes PS Hybrid Contact LensSynergeyes, Inc.20062—
+2K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.20160—