# K031522: Solo-Care Plus Multipurpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Jun 27, 2003 after 43 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012731 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012731: Solo-Care Plus Multipurpose Solution, Ciba Vision Corporation (2001) Summary page 1.

## Recalls of this device
- Sep 27, 2004 · Not classified · Z-0028-05: Stability tests at 24 months revealed failing results for disinfection efficacy.

## Indications for use
SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting,daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K031522
Methodology: https://510kreport.com/methodology