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510(k) Data Aggregation
K Number
K151768Device Name
Menicon Saline Rinse Solution
Manufacturer
MENICON CO.,LTD.
Date Cleared
2015-08-28
(59 days)
Product Code
LPN, MRC
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
MENICON CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
Device Description
The Menicon Saline Rinse Solution is a sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution indicated for rinsing soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. This sterile, normal saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.
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