510(k) · Cleared
ClearedNusoft Spherical, Toric, Aspheric and Bifocal (Ocufilcon B) Soft Contact Lenses for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softfocal Company, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jan 10, 2003 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 10, 2003
- Review
- 58 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?
The NuSoft Spherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity. The NuSoft Toric (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic…
Read the full statement (209 words)
The NuSoft Spherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.
The NuSoft Toric (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
The NuSoft Aspherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D that does not interfere with visual acuity.
The NuSoft Bifocal (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023791: Nusoft Spherical, Toric, Aspheric and Bifocal (Ocufilcon B) Soft Contact Lenses 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/K023791
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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