510(k) Report

Devices descending from K062854

7 later devices reach Benz-G 4X Hioxifilcon D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49…Contamac, Ltd.20151—
+1K101122Benz-G 4X (Hioxifilcon D) Multifocal Lathed LensBenz Research and Development Corp.20100—
+1K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA20083—
+2K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL…Eyeyon Medical20160—
+2K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110—
+2K100456Cvue Advanced DefinitiveUnilens Corp., USA20102—
+3K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—