510(k) · Cleared
ClearedSatureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metro Optics of Austin, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 1, 2003 as substantially equivalent to K953199 (Metrosoft, Inc., 1995) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 1, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953199 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953199 Metro 55G Toric & SphericalMetrosoft, Inc. · 1995
- This deviceK031532 Satureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft…Metro Optics of Austin, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953199 | Metro 55G Toric & Spherical | Metrosoft, Inc. | 1995 | — |
| 0 (this device) | K031532 | Satureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft Contact Lens… | Metro Optics of Austin, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953199 | Metro 55G Toric & SphericalSummary page 2…ice name: Metro Optics of Austin, Ltd. Metro-G 55 (5X) (hioxifilcon A) Spherical & Toric 15802 Vision Drive 5 1 O(k) #: K953 199 Pflugerville, TX 78660 Metro-G 3X (hioxifilcon B) Spherical & Toric Soft… | 1995 |
| * | K964902 | Contact Lenses Metro-G 3X (Hioxifilcon B)Summary page 2…con B) Spherical & Toric Soft Contact Lenses for Daily Wear 5 1O(k) # K964902 MetroFocal Toric Multifocal (hioxifilcon A) Soft Daily Wear… | 1997 |
| * | K001584 | Metrofocal Toric (Hioxifilcon a) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue… | 2000 |
| † | K023349 | Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and… | 2002 |
| † | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and… | 2003 |
| † | K954139 | Aquasoft (Tetrafilcon a) Daily Wear Soft (Hydrophilic) Contact Lens | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K953199.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
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…
Read the full statement (237 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031532: Satureeyes II (Acofilcon a), (Acofilcon B) & (Tetrafilcon a) Soft Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031532
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026