# K201013: Optixon 1-Day

- Pathway: 510(k) (Traditional)
- Applicant: Optixon, Inc.
- Decided: Sep 18, 2020 after 154 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003136 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A), Supervision Optimax Sdn Bhd (2017) Summary page 5.
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses, CooperVision, Inc. (2011) Summary page 5.

## Indications for use
OPTIXON 1- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.

Source page: https://510kreport.com/device/K201013
Methodology: https://510kreport.com/methodology