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510(k) Data Aggregation
K Number
K162869Device Name
Contact Lens Case
Manufacturer
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Date Cleared
2016-12-09
(57 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
Ningbo Yinzhou Zonghai Artware Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.
Device Description
The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.
The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.
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