# K200747: PuriLens Plus Preservative Free Saline

- Pathway: 510(k) (Traditional)
- Applicant: The Lifestyle Company, Inc.
- Decided: May 15, 2020 after 53 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002319 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002319: Purilens Saline Solution, Purilens, Inc. (2000) Summary page 4.

## Most influential descendants
- K221263: Aqua Naina Plus Sterile Saline Solution (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200747
Methodology: https://510kreport.com/methodology