# K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Clearlab Pte, Ltd.
- Decided: May 15, 2006 after 265 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: 3 generations back to K962804 (1996). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 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.
- K983773: Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens, Benz Research and Development Corp. (1998) Summary page 2.
- K030167: Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker, Clearlab Pte, Ltd. (2003) Summary page 2.

## Most influential descendants
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens (2008), 3 descendants of its own
- 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
- K170286: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA (2017), 0 descendants of its own

## Indications for use
The AQUASOFT ALL-DAY (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. The AQUASOFT ALL-DAY T (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.OOD of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K052290
Methodology: https://510kreport.com/methodology