# K040914: Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics

- Pathway: 510(k) (Traditional)
- Applicant: Exero Products, Inc.
- Decided: May 27, 2004 after 49 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: 4 generations back to K951552 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971618: Alcon Contact Lens Case, Alcon Laboratories (1997) Summary page 2.
- K974281: Alcon Contact Lens Case, Alcon Laboratories (1998) Summary page 2.
- K993486: Paragon Lens Carrier, Paragon Vision Sciences (1999) Summary page 2.
- K993487: Paragon Lens Vial, Paragon Vision Sciences (1999) Summary page 2.
- K013232: Cybercases by Bausch & Lomb, Bausch & Lomb, Inc. (2001) Summary page 2.
- K030987: Contact Lens Storage Case, Pelican Products (2003) Summary page 2.

## Indications for use
PolyVial/ PolyPak Contact Lens Case storage system by Exero .Products is indicated for storage of hard, RGP (Rigid Gas Permeable) fitro silicone acylate and silicone acrylate and Soft (bydrophilic) contact lenses during chemical disinfection

Source page: https://510kreport.com/device/K040914
Methodology: https://510kreport.com/methodology