510(k) Report

Devices descending from K990264

30 later devices reach Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.2004282
+1K024164Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas…Metro Optics, Inc.20030—
+2K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.20168—
+2K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.20160—
+2K152724Eyeprintpro (Roflufocon D) Scleral GP LensesAdvanced Vision Technologies20160—
+2K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight201620—
+2K062548Modification to Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.20060—
+3K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20214—
+3K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E…Valley Contax, Inc.20210—
+3K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…Paragon Vision Sciences20180—
+3K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.20171—
+3K161461BostonSight PD Prosthetic DeviceBostonsight2016191
+4K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc.20243—
+4K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.20227—
+4K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20216—
+4K183175BostonSight ScleralBostonsight201911
+4K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated201714—
+4K170335Custom Stable (TM) Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.20171—
+5K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.20260—
+5K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240—
+5K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.20240—
+5K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—
+5K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC20244—
+5K230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A)…Acculens, Inc.20230—
+5K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesParagon Vision Sciences, Inc.20230—
+5K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC20225—
+5K213880Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.20220—
+5K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Bausch & Lomb, Incorporated20195—
+5K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd.20189—
+6K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™…Acuity Polymers, Inc.20234—