MRC — Products, Contact Lens Care, Rigid Gas Permeable Class II

FDA Device Classification

Classification Details

Product Code
MRC
Device Class
Class II
Regulation Number
886.5918
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251876ophtecs corporationcleadew GP hydra oneOctober 9, 2025
K200416bausch and lomb, incorporatedBoston One Step Liquid Enzymatic CleanerSeptember 23, 2020
K201069dry eye innovationsVibrantVue Scleral SalineJuly 31, 2020
K182984omnivisionMaxiTears Contacts PFJuly 24, 2019
K181566contamacNutrifillOctober 22, 2018
K181627bausch and lomb, incorporatedBausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One StepAugust 10, 2018
K180319bausch and lomb, incorporatedBausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning March 27, 2018
K173089bausch and lomb, incorporatedBausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original ConditioninNovember 27, 2017
K173136menicon coMenicon Progent Protein Remover for Rigid Gas Permeable Contact LensesNovember 16, 2017
K130805menicon coMENICON UNIQUE PH MULTI-PURPOSE SOLUTIONJuly 3, 2013
K122273menicon coMENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSJanuary 2, 2013
K082855menicon coMENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMarch 9, 2010
K052074szabocsik and associatesJSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSSeptember 1, 2005
K040839advanced medical opticsCOMPLETE BLINK-N-CLEAN LENS DROPSOctober 19, 2004
K024289bausch and lomb, incorporatedBOSTON BL-1000-SIM08 MULTI-ACTION SOLUTIONMay 2, 2003
K023455ciba vision corporationAOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTIONFebruary 28, 2003
K020930menicon coMENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMay 2, 2002
K013204ciba vision corporationAQUIFY LENS COMFORT DROPSApril 3, 2002
K014162lobob laboratoriesMODIFICATION TO OPTIMUM CLEANING, DISINFECTING ANDJanuary 15, 2002
K011456sauflon pharmaceuticalsDELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSESJuly 17, 2001