510(k) Report

510(k) · Cleared

Cleared

SEE3 (Lotrafilcon a) Soft Contact Lens

K970746510(k) TraditionalCleared May 9, 199770-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ciba Vision Corporation · LPL Lenses, Soft Contact, Daily Wear

Cleared on May 9, 1997 as substantially equivalent to P810005 (Ciba Vision Care, 1981) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1981. 96 later devices descend from it.

Decided
May 9, 1997
Review
70 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to P810005 (1981). 2 ancestors in all. 96 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1984: 1 other ancestor2008: 2 descendants cleared2005: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2004: 1 descendant cleared2016: 9 descendants cleared2010: 4 descendants cleared2012: 5 descendants cleared2015: 3 descendants cleared2025: 6 descendants cleared2021: 5 descendants cleared2011: 3 descendants cleared2018: 8 descendants cleared2013: 4 descendants cleared2014: 5 descendants cleared2006: 1 descendant cleared2019: 4 descendants cleared2023: 3 descendants cleared2024: 12 descendants cleared2020: 4 descendants cleared2017: 5 descendants cleared2022: 4 descendants cleared2026: 5 descendants clearedP810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 25 descendants3 generations forward: 28 descendants4 generations forward: 18 descendants5 generations forward: 9 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants8 generations forward: 4 descendants P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 19810+5
  1. Root · 1 generation backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
  2. This deviceK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
  3. Descendant · cites it directly · 95 of its ownK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
  4. Descendant · 2 generations on · 94 of its ownK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
  5. Descendant · cites it directly · 74 of its ownK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
  6. Descendant · 2 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
  7. Descendant · cites it directly · 17 of its ownK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 12006: 12008: 22009: 12010: 42011: 32012: 52013: 42014: 52015: 32016: 92017: 52018: 82019: 42020: 42021: 52022: 42023: 32024: 122025: 62026: 5
2002high 12 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 96 · See all
  • K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002 · cites it directly95descendants
  • K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsCiba Vision Corporation · 2004 · 2 generations on94descendants
  • K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · cites it directly74descendants
  • K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 2 generations on32descendants
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008 · cites it directly17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P810005Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care1981—
0 (this device)K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation1997—
+1K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation2002—
+2K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal…Ciba Vision Corporation20041
+1K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.20051
+2K100221INTELLIWAVE3Art Optical Contact Lens, Inc.2010—
+1K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200610
200820
200910
201040
201130
201250
201340
201450
201530
201690
201750
201880
201940
202040
202150
202240
202330
2024120
202560
202650
FIG. 1 — Lineage of K970746, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*P810005Weicon (R) (Tefilicon) Hydrophilic Contact Lens
Summary page 1
…(FDA Group |: low water, nonionic polymer): . Cibasoft® (teficon), FDA Group |, low water, nonionic soft contact lenses for daily wear; CIBAVision® Corporation - PMAs P810005, P820086 Premarket Notification 510{k) : clear (loraficon A) Soft Contact Lens Part IX. Summary of Satety & Substantial Equivale…
Ciba Vision Care1981—
*P820086Cibatint (TM) Tinting Process
Summary page 1
…up |: low water, nonionic polymer): . Cibasoft® (teficon), FDA Group |, low water, nonionic soft contact lenses for daily wear; CIBAVision® Corporation - PMAs P810005, P820086 Premarket Notification 510{k) : clear (loraficon A) Soft Contact Lens Part IX. Summary of Satety & Substantial Equivalence, Rev:…
Ciba Vision Care19842

Also cleared against P810005: 2 other devices →

What descends from it? (96)

See all 96

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation200295
K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.200574
K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation200817
K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc.20091

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K020139 (Ciba Vision Corporation, 2002) has gone furthest, with 95 descendants of its own.
  • 2 other devices also cite its predicate P810005.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

SEE3™ (lotrafilcon A) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection and monthly replacement. SEE3™ (lotrafilcon A) lenses may be cleaned using a chemical, not heat, disinfection system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against P810005

2 other devices cite the same predicate.

  • K023732Cibasoft Progressive Toric (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily WearCiba Vision Corporation · 2002
  • K011893Cosmetica (Polymacon) Soft (Hydrophilic) Contact LensesContact Color Srl · 2001

More from Ciba Vision Corporation

210 FDA decisions under this applicant name. See the company

  • K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
  • K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus MultifocalCiba Vision Corporation · 2013
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal ToricCiba Vision Corporation · 2012
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K970746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970746: SEE3 (Lotrafilcon a) Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970746

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026