510(k) · Cleared
ClearedAir Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal
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
Cleared on Jan 29, 2014 as substantially equivalent to K073459 (Ciba Vision Corporation, 2008) and 1 other predicate after a 104-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.
- Decided
- Jan 29, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P810005 (1981). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 4 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 3 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 2 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 1 generation backK073459 Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
- This deviceK133176 Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
- Descendant · cites it directly · 1 of its ownK172600 AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS MultifocalAlcon Laboratories, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK222500 Air Optix ColorsAlcon Laboratories, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −4 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −3 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −2 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −1 | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact Lenses | Ciba Vision Corporation | 2008 | — |
| 0 (this device) | K133176 | Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal | Ciba Vision Corporation | 2014 | — |
| +1 | K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | Alcon Laboratories, Inc. | 2017 | — |
| +2 | K222500 | Air Optix Colors | Alcon Laboratories, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesSummary page 1…5925 (b) (1)] 3. Predicate Device: The predicate devices are Ciba Vision AIR OPTIX® AQUA (lotrafilcon B) soft contact lenses cleared under Premarket Notification 510(k) K073459 and Ciba Vision FreshLook ColorBlends® (phemfilcon A) soft contact lenses, approved for daily and extended wear under PMA P83003… | 2008 |
| * | P830037 | Durasoft (R) 3 for Ext WearSummary page 1…ed under Premarket Notification 510(k) K073459 and Ciba Vision FreshLook ColorBlends® (phemfilcon A) soft contact lenses, approved for daily and extended wear under PMA P830037/S047. 4. Description of Device: The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel whi… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | 2017 | 1 |
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?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K172600 (Alcon Laboratories, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K073459.
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. 2014, this device’s year, is highlighted.
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?
AIR OPTiX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. AIR OPTIX® COLORS Toric (lotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive…
Read the full statement (196 words)
AIR OPTiX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
AIR OPTIX® COLORS Toric (lotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
AIR OPTIX® COLORS Multifocal (lotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.
The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133176: Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133176
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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