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PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations. The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.