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U.S. Department of Health and Human Services

Product Classification

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Device hydrophilic re-coating solution
Definition A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only.
Physical State This device is a reactive hydrophilic solution that is packaged sterile and is not intended to be reused.
Technical Method A hydrophilic re-coating solution chemically reacts with the lens surface to restore the hydrophilic coating on specific types of RGP contact lenses. The device is only compatible with a subset of rigid gas permeable contact lenses. Lens compatibility with the device depends on the material that the lens is made of and the presence of a specific type of coating on the lens when it was originally manufactured. Over time, this coating wears off and can be restored with the coating solution.
Target Area The device is intended to be used as a treatment for contact lenses. The device is not intended to clean or disinfect lenses and must be used with a compatible care product for cleaning and disinfection. Cleaning and disinfection with a compatible care product must occur before the contact lenses are safe for patient wear. The patient is warned not to use this product in their eye directly.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQMM
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5919
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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