510(k) Report

Devices descending from K000795

50 later devices reach Rigid Gas Permeable Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.20260—
+1K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc.2007262
+1K051035Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact LensSynergeyes20055—
+1K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.2004282
+1K032256Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas…No 7 Contact Lens Laboratory, Ltd.20030—
+1K021752FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens AsphericalLucid Korea Co., Ltd.20020—
+1K020006Dyna Intra-Limbal LensLens Dynamics, Inc.200239—
+2K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Bausch & Lomb, Incorporated20195—
+2K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact…E&E Optics, Inc.20180—
+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—
+2K120996Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151…Paragon Vision Sciences20121—
+2K103561Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensMenicon Co, Ltd.20110—
+2K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc.20091—
+2K081443Menicon Z Rigid Gas Permeable Contact LensMenicon Co, Ltd.20081—
+2K070628Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens.Contamac, Ltd.200710—
+2K062548Modification to Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.20060—
+2K060102Synergeyes PS Hybrid Contact LensSynergeyes, Inc.20062—
+2K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Bausch & Lomb, Incorporated200638—
+2K052675Synergeyes KC (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for KeratoconusSynergeyes20053—
+3K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—
+3K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™…Acuity Polymers, Inc.20234—
+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—
+3K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20170—
+3K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.20160—
+3K161461BostonSight PD Prosthetic DeviceBostonsight2016191
+3K142510UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact…Synergeyes, Inc.20141—
+3K102154Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric…The Lagado Corp.20115—
+3K071043Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…Bausch & Lomb, Inc.2007142
+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—
+4K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20169—
+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—
+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—
+5K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20207—
+5K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd.20189—