# K221263: Aqua Naina Plus Sterile Saline Solution

- Pathway: 510(k) (Special)
- Applicant: Chemtex USA, Inc.
- Decided: Oct 12, 2022 after 163 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: 5 generations back to K002319 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193441: Aqua Naina Sterile Saline Solution, Chemtex USA, Inc. (2020) Summary page 5.
- K200747: PuriLens Plus Preservative Free Saline, The Lifestyle Company, Inc. (2020) Summary page 5.
- K151768: Menicon Saline Rinse Solution, Menicon Co, Ltd. (2015) Summary page 5.
- K201069: VibrantVue Scleral Saline, Dry Eye Innovations, LLC (2020) Summary page 5.

## Indications for use
Aqua Naina Plus Sterile Saline Solution The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may 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 Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. Aqua Naina Sterile Saline Solution The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

Source page: https://510kreport.com/device/K221263
Methodology: https://510kreport.com/methodology