# K143351: iCase Contact Lens Case

- Pathway: 510(k) (Traditional)
- Applicant: Novabay Pharmaceuticals, Inc.
- Decided: Apr 29, 2015 after 156 days
- Product code: LRX (Case, Contact Lens)
- 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)
- 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 4.

## Indications for use
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.

Source page: https://510kreport.com/device/K143351
Methodology: https://510kreport.com/methodology