PMA · Approved
ApprovedWeicon (R) (Tefilicon) Hydrophilic Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Care · LPM Lenses, Soft Contact, Extended Wear
Approved on Sep 24, 1981 through premarket approval, which rests on the device’s own clinical evidence after a 216-day review. 99 later devices descend from it.
- Decided
- Sep 24, 1981
- Review
- 216 days
- Class
- Class III
- Product code
- LPM
- Recalls
- None
99 later devices descend from it, 3 citing it directly.
- This deviceP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- Descendant · cites it directly · 96 of its ownK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- Descendant · 2 generations on · 95 of its ownK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- Descendant · 3 generations on · 94 of its ownK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- Descendant · 2 generations on · 74 of its ownK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997 · cites it directly96descendants
- K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002 · 2 generations on95descendants
- K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsCiba Vision Corporation · 2004 · 3 generations on94descendants
- K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · 2 generations on74descendants
- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| +1 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| +2 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| +3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| +2 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| +3 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 9 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 12 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 LPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (99)
See all 993 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K970746 (Ciba Vision Corporation, 1997) has gone furthest, with 96 descendants of its own.
How does its category compare?
All LPM devicesLPM Lenses, Soft Contact, Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPM
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPM
Too few LPM 510(k)s in any year since 2007 to give a median.
Recalls per year · LPM
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPM
111in 2025
MAUDE reports naming product code LPM, 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 | 4 | — | 1 | 68 |
| 2008 | 15 | — | 0 | 42 |
| 2009 | 12 | — | 0 | 56 |
| 2010 | 30 | — | 3 | 108 |
| 2011 | 51 | — | 0 | 155 |
| 2012 | 49 | — | 0 | 181 |
| 2013 | 31 | — | 0 | 172 |
| 2014 | 26 | — | 3 | 111 |
| 2015 | 35 | — | 0 | 143 |
| 2016 | 43 | — | 0 | 220 |
| 2017 | 79 | — | 1 | 215 |
| 2018 | 59 | — | 1 | 195 |
| 2019 | 55 | — | 0 | 189 |
| 2020 | 45 | — | 0 | 107 |
| 2021 | 28 | — | 0 | 103 |
| 2022 | 40 | — | 0 | 82 |
| 2023 | 15 | — | 0 | 118 |
| 2024 | 31 | — | 0 | 163 |
| 2025 | 31 | — | 0 | 111 |
| 2026 | 23 | — | 0 | — |
https://510kreport.com/device/P810005 · printed Nov 4, 2026
Cite this page
510(k) Report. “P810005: Weicon (R) (Tefilicon) Hydrophilic Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P810005
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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