# K032309: Novelens Contact Lens Cleaning Enhancement and Storage Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Novelens, Inc.
- Decided: Dec 4, 2003 after 132 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
Longest line of descent: 3 generations back to K915082 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013232: Cybercases by Bausch & Lomb, Bausch & Lomb, Inc. (2001) Summary page 1.
- K852384: Sight Saver All Purpose Lens Carrying Case, Bausch & Lomb, Inc. (1985) Summary page 1.
- K971618: Alcon Contact Lens Case, Alcon Laboratories (1997) Summary page 1.
- K974281: Alcon Contact Lens Case, Alcon Laboratories (1998) Summary page 1.
- K021248: ICASE, Ikeeps, Inc. (2002) Summary page 1.

## Indications for use
The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.

Source page: https://510kreport.com/device/K032309
Methodology: https://510kreport.com/methodology