| 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 Code | QMM |
|---|
| Premarket Review |
Ophthalmic Devices
(DHT1A)
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 |
