# K983291: Solo-Care Brand Multi-Purpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Nov 25, 1998 after 65 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P950010: BOSTON Simplicity Multi-action Solution. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
SOLO-Care ™ Brand Multi-Purpose Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K983291
Methodology: https://510kreport.com/methodology