# K162597: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Oct 19, 2016 after 30 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: 2 generations back to K003345 (2001). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820040: Septicon (TM) Disinfection Regimen for Use with, Ciba Vision Care. FDA lists this PMA only through its supplements; the earliest we hold is P820040/S001 (Dec 23, 1983). Summary page 5.
- K003345: Aosept Plus Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 5.
- K013512: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 5.
- K022687: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2002) Summary page 5.
- K023455: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.
- K030522: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.
- K031521: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 5.

## Most influential descendants
- K173538: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (2017), 1 descendant of its own
- K191795: AOCup Lens Case with AODisc (2019), 0 descendants of its own

## Indications for use
For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K162597
Methodology: https://510kreport.com/methodology