510(k) · Cleared
ClearedDurasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wesley Jessen Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jan 4, 1996 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 4, 1996
- Review
- 92 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK954603 Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite TintWesley Jessen Corp. · 1996
- Descendant · cites it directly · 4 of its ownK013377 Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK182523 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK242916 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK202129 Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK152657 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K013377Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 2001 · cites it directly4descendants
- K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2018 · 2 generations on2descendants
- K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2025 · 3 generations on0descendants
- K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB…Largan Medical Co., Ltd. · 2021 · 3 generations on0descendants
- K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954603 | Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint | Wesley Jessen Corp. | 1996 | — |
| +1 | K013377 | Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| +2 | K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2018 | — |
| +3 | K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2025 | — |
| +3 | K202129 | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens… | Largan Medical Co., Ltd. | 2021 | — |
| +2 | K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | Smart Performer Corp., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013377 | Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 2001 | 4 |
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?
- Of its descendants, K013377 (Ocular Sciences Puerto Rico, Inc., 2001) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K954603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954603: Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954603
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026