# K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

- Pathway: 510(k) (Traditional)
- Applicant: Supervision Optimax Sdn Bhd
- Decided: Jan 4, 2017 after 149 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: 5 generations back to K003136 (2001). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses, CooperVision, Inc. (2011) Summary page 4.
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens, CooperVision, Inc. (2006) Summary page 4.

## Most influential descendants
- K180985: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (2018), 1 descendant of its own
- K253885: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES (2026), 0 descendants of its own
- K213983: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (2022), 0 descendants of its own
- K201013: Optixon 1-Day (2020), 0 descendants of its own

## Indications for use
Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.

Source page: https://510kreport.com/device/K162223
Methodology: https://510kreport.com/methodology