# K031532: Satureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics of Austin, Inc.
- Decided: Aug 1, 2003 after 78 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: 1 generation back to K953199 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953199: Metro 55G Toric & Spherical, Metrosoft, Inc. (1995) Summary page 2.
- K964902: Contact Lenses Metro-G 3X (Hioxifilcon B), Metro Optics of Austin, Inc. (1997) Summary page 2.
- K001584: Metrofocal Toric (Hioxifilcon a) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-Cut, Medvice Consulting, Inc. (2000)

## Indications for use
The SatureEyes 11 (acofilcon A), (acofilcon B) & (tetrafilcon 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 .75 diopters or less where the astigmatism does not interfere with visual acuity. The SatureEyes I1 (acofilcon A), (acofilcon B) & (tetrafilcon 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 10.00 diopters or less where the astigmatism does not interfere with visual acuity. The SatureEyes I1 (acofilcon A), (acofilcon B) & (tetrafilcon A) Multifocal 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 are presbyopic. The SatureEyes I1 (acofilcon A), (acofilcon B) & (tetrafilcon A) Toric Multifocal 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, have astigmatism of 10.00 diopters or less and are presbyopic. Eyecare practitioners may prescribe the lens for frequend/planned replacement wear, with cleaning disinfection and scheduled replacement: When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Source page: https://510kreport.com/device/K031532
Methodology: https://510kreport.com/methodology