# K253885: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES

- Pathway: 510(k) (Traditional)
- Applicant: Geo Medical CO., LTD.
- Decided: Apr 29, 2026 after 146 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: 7 generations back to K003136 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180985: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses, Supervision Optimax Sdn Bhd (2018) Summary page 6.

## Indications for use
The Puscon Water Balance-1Day Tint (omafilcon A) Soft (Hydrophilic) Contact Lens and Puscon Water Balance-1Day Color (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for single use for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia. The lenses may be worn by people who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available tinted and may be used to enhance or alter the apparent color of the eye. The lenses are to be discarded after each removal.

Source page: https://510kreport.com/device/K253885
Methodology: https://510kreport.com/methodology