# K102895: One Day Flat Pack

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Apr 28, 2011 after 210 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 K962804 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens, Clearlab SG Pte, Ltd. (2008) Summary page 2.

## Most influential descendants
- K180819: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (2018), 0 descendants of its own

## Indications for use
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

Source page: https://510kreport.com/device/K102895
Methodology: https://510kreport.com/methodology