510(k) Report

Devices descending from K022128

24 later devices reach Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20171—
+1K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight201620—
+1K103561Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensMenicon Co, Ltd.20110—
+2K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact…E&E Optics, Inc.20180—
+2K161461BostonSight PD Prosthetic DeviceBostonsight2016191
+3K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.20227—
+3K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20216—
+3K183175BostonSight ScleralBostonsight201911
+3K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated201714—
+3K170335Custom Stable (TM) Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.20171—
+4K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.20260—
+4K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.20240—
+4K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—
+4K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC20244—
+4K230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A)…Acculens, Inc.20230—
+4K221768Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesParagon Vision Sciences, Inc.20230—
+4K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC20225—
+4K213880Custom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.20220—
+4K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20214—
+4K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Bausch & Lomb, Incorporated20195—
+4K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd.20189—
+5K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240—
+5K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc.20243—
+5K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™…Acuity Polymers, Inc.20234—