# K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Clearlab SG Pte, Ltd.
- Decided: Oct 15, 2008 after 224 days
- Product code: MVN (Lens, Contact, (Disposable))
- 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: 4 generations back to K962804 (1996). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992692: Extreme H20 (Hioxifilicon a) Soft Contact Lens, Benz Research and Development Corp. (1999) Summary page 2.
- K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens, Clearlab Pte, Ltd. (2006) Summary page 2.

## Most influential descendants
- K102895: One Day Flat Pack (2011), 1 descendant of its own
- K192129: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (2019), 0 descendants of its own
- K180819: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (2018), 0 descendants of its own

## Indications for use
The Clearn-day ® (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/K080632
Methodology: https://510kreport.com/methodology