510(k) · Cleared
ClearedMetrosoft II, Metrosoft Toric, Metrolite, Metrotint, Satureyes, Satureyes Toric, Satureyes Lite, Satureyes Lite Toric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metrosoft, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 13, 1998 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 13, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
MetroSoft 1II, MetroTint and MetroLite contact lens are indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters. MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or…
Read the full statement (189 words)
MetroSoft 1II, MetroTint and MetroLite contact lens are indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters.
MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or aphakic and who have refractive and/or comeal astigmatism of up to 6.00 diopters and require powers from -20.00 to +20.00 diopters.
SaturEyes spherical (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 1.5 Diopters where the astigmatism does not interfere with visual acuity.
SaturEyes Toric (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and corneal astigmatism of up to 4.00 Diopters or less where the astigmatism does not interfere with visual acuity.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983021: Metrosoft II, Metrosoft Toric, Metrolite, Metrotint, Satureyes, Satureyes Toric, Satureyes Lite, Satureyes Lite Toric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026