# K221768: Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences, Inc.
- Decided: May 5, 2023 after 322 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943177 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B), Bausch + Lomb, Incorporated (2017) Summary page 4.

## Indications for use
The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K221768
Methodology: https://510kreport.com/methodology