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510(k) Data Aggregation
K Number
K160005Device Name
Contact Lens Case (multiple brand name)
Manufacturer
DANYANG CHANXIN GLASSES CASES FACTORY
Date Cleared
2016-06-07
(155 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
DANYANG CHANXIN GLASSES CASES FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic) contact lenses while not being worn. Not designed for heat disinfecting system. Use only with chemical disinfection.
Device Description
Contact Lens Case is a lens care product to be used by the contact lens wearer or practitioner for storing soft(hydrophilic) contact lenses while not being worn. This device is not sterile and not for heat-disinfection. Use only with chemical disinfection.
There are two main series includes the variant model DC-2001, DC-3001 and DC-6001, the other includes DC-7001 and DC-8001. All these five variant models are made of Polypropylene, which follow the same design principle with the same intended use.
All the five variant models of this device have a capacity of over 1.5 ml in each case well. And the inner height of the all wells exceeds 8.5 mm. With regard to the Center Thickness of the normal hydrophilic and hydrophobic contact lens will not outnumber 8.5 mm, the capacity is sufficient for contact lens to be fully immersed under use condition.
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