# K031957: Modification to Karats Multi-Purpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Aug 14, 2003 after 50 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
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 FDA summary names its predicate without a number.
- (no number) KARATS Multi-purpose Solution: named in the summary without a submission number

## Indications for use
Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K031957
Methodology: https://510kreport.com/methodology