PMA · Approved
ApprovedExcelens (Atlafilcon a) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LPL Lenses, Soft Contact, Daily Wear
Approved on Dec 28, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 239-day review. 27 later devices descend from it.
- Decided
- Dec 28, 1989
- Review
- 239 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
27 later devices descend from it, 1 citing it directly.
- This deviceP890029 Excelens (Atlafilcon a) Contact LensCiba Vision Corporation · 1989
- Descendant · cites it directly · 26 of its ownK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- Descendant · 2 generations on · 22 of its ownK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- Descendant · 2 generations on · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- Descendant · 2 generations on · 12 of its ownK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
- Descendant · 2 generations on · 11 of its ownK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K963487Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · cites it directly26descendants
- K992446Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999 · 2 generations on22descendants
- K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · 2 generations on21descendants
- K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation · 2003 · 2 generations on12descendants
- K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P890029 | Excelens (Atlafilcon a) Contact Lens | Ciba Vision Corporation | 1989 | — |
| +1 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| +2 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| +2 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| +2 | K033701 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft… | Ciba Vision Corporation | 2003 | — |
| +2 | K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives | Ciba Vision Corporation | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | 1996 | 26 |
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, K963487 (Ciba Vision Corporation, 1996) has gone furthest, with 26 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/P890029 · printed Nov 4, 2026
Cite this page
510(k) Report. “P890029: Excelens (Atlafilcon a) Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P890029
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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