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510(k) Data Aggregation
K Number
K131783Device Name
POLAROID CONTACTSPOD
Manufacturer
Date Cleared
2014-02-21
(249 days)
Product Code
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
VIOPTI LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Contactspod is a sterile single-use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. It is not a replacement for your normal contact lens rub and rinse cleaning and disinfecting care regime. It is a clear solution and should not be used, if cloudy or discoloured. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
Device Description
The Contactspod is a sterile single use temporary storage case and contains multi-purpose contact lens solution for use with soft contact lenses. The Contactspod comprises an injection mouided medical grade polypropylene case and medical grade TPE basket seal. The contactspod is pre filled with 5ml of multi-purpose solution. The MPS solution is supplied inside the moulded PP case with an aluminium / PE heatseal which is removed by the user. Once lenses are inserted into the solution a secondary seal is used to seal the case.
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