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510(k) Data Aggregation
K Number
K120904Device Name
POLARIS DIAL-A-DATE CONTACT LENS CASE
Manufacturer
RELIANCE DESIGN & MANUFACTURE CORP.
Date Cleared
2012-11-26
(245 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
**RELIANCE DESIGN **& MANUFACTURE CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polaris 'Dial-A-Date' is a contact lens case for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses. Use for storage during chemical disinfection only. Not for use during heat disinfection.
Device Description
The Polaris Dial-a-Date contact lens case is a device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. Contact lenses can be fully immersed into the chamber and accommodates all lenses currently being sold in the market. The contact lens case consists of a molded dual compartment bottom base and two screwdown lids. The bottom of each compartment is marked with L (left) and R (right). The lids are also labeled with L (left) and R (right), and include a dial with molded-in numbers from 0 to 3 and 0 to 9, respectively. The outer lids are colored to make the molded-in numbers of the dials visible at the 'dialed position'. The dials can be incrementally rotated to let the user set reminders (i.e. day of the month to replace the contact lenses). The outer lids and number dials do not come into contact with the lens care solution.
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K Number
K093377Device Name
POLARIS CONTACT LENS CASE
Manufacturer
RELIANCE DESIGN & MANUFACTURING CORP.
Date Cleared
2010-04-27
(180 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
**RELIANCE DESIGN **& MANUFACTURING CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.
Device Description
Polaris Contact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. This device is intended for use with a contact lens solution to store the contact lenses, This product is not to be used in heat disinfection. This device is manufactured in two variations: #101 and #201. The variants follow the same design principles and have the same intended use. The only differences are the dimensions and appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The primary materials which compose the applicant device are ST757M and PT231M; they are produced by Taiwan Polypropylene Co., Ltd. ST757M is a translucent raw material and PT231M is an opaque white raw material. The Polymer 27A55 is produced by Kraton Polymers UK Ltd. The volume of each of the two chambers in the applicant device #101 contact lens case is 4.5ml. The volume of each of the two chambers in the applicant device #201 contact lens case is 3ml. Contact lenses can be fully immersed into the chamber; both models can accommodate all lenses currently on the market.
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