FDA.reportPublic FDA data

510(k) K000975

Device
LIPIDURE REWETTING DROPS
Applicant
NOF CORP.
510(k) number
K000975
Product code
MRC  
Decision
Substantially Equivalent (SESE)
Decision date
2000-09-25
Date received
2000-03-27
Regulation
886.5918
Classification name
Products, Contact Lens Care, Rigid Gas Permeable
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANN KUROWSKI
Address
269 A Ballardvale St. Wilmington MA US 01887 01887

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251876cleadew GP hydra oneOphtecs Corporation2025-10-09
K200416Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated2020-09-23
K201069VibrantVue Scleral SalineDry Eye Innovations, LLC2020-07-31
K182984MaxiTears Contacts PFOmnivision AG2019-07-24
K181566NutrifillContamac, Ltd.2018-10-22
K181627Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated2018-08-10
K180319Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionBausch and Lomb, Incorporated2018-03-27
K173089Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning SolutionsBausch & Lomb, Incorporated2017-11-27
K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd.2017-11-16
K130805MENICON UNIQUE PH MULTI-PURPOSE SOLUTIONMenicon Co, Ltd.2013-07-03
K122273MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.2013-01-02
K082855MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMenicon Co, Ltd.2010-03-09
K052074JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,Szabocsik and Associates2005-09-01
K040839COMPLETE BLINK-N-CLEAN LENS DROPSAdvanced Medical Optics, Inc.2004-10-19
K024289BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTIONBausch & Lomb, Incorporated2003-05-02

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases