510(k) · Cleared
ClearedINTELLIWAVE3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Art Optical Contact Lens, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 14, 2010 as substantially equivalent to K073621 (Art Optical Contact Lens, Inc., 2008) and 2 other predicates after a 231-day review. Its family tree reaches back 5 generations to 1981. 32 later devices descend from it.
- Decided
- Sep 14, 2010
- Review
- 231 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to P810005 (1981). 14 ancestors in all. 32 later devices descend from it, 11 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 backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- This deviceK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 2 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
- Descendant · cites it directly · 8 of its ownK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · cites it directly12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 2 generations on11descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · 3 generations on8descendants
- K100244Metro SoftMetro Optics of Austin, Inc. · 2010 · cites it directly8descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on5descendants
View 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 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| 0 (this device) | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +1 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +2 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| +3 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
| +1 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
| +2 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Summary page 2…"IntelliWavel and Intelliwave2 (acofilcon B, hioxifilcon B)" by Art Optical Contact Lens, Inc. 5 10(k) number; K073621 "Biofinity (conifilcon A)" by Coopervision, Inc. 5… | 2008 |
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 2…5 10(k) number; K073621 "Biofinity (conifilcon A)" by Coopervision, Inc. 5 10(k) number; K052560 "ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 5 10… | 2005 |
| * | K983637 | Actifresh 400 LensSummary page 2…5 10(k) number; K052560 "ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 5 10(k) number: K983637 Device Description: The IntelliWave 3 Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dr… | 1999 |
What descends from it? (32)
See all 3211 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142641 | Intelliwave4 | 2015 | 12 |
| K100244 | Metro Soft | 2010 | 8 |
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | 2023 | 2 |
| K100456 | Cvue Advanced Definitive | 2010 | 2 |
| K100443 | Definitive, Flexlens - Silicone Hydrogel | 2010 | 1 |
| K191121 | Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for… | 2019 | 0 |
| K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses… | 2014 | 0 |
| K121652 | Cvue Advanced Hydra Vue | 2012 | 0 |
| K121519 | Isight | 2012 | 0 |
| K121324 | Avt Naturasoft | 2012 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K142641 (Art Optical Contact Lens, Inc., 2015) has gone furthest, with 12 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. 2010, 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?
The IntelliWave 3 , sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Intelli Wave 3 , toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses…
Read the full statement (304 words)
The IntelliWave 3 , sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Intelli Wave 3 , toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the cprrection of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The IntelliWave 3 , multifocal (efirofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave3t multifocal toric (efirofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to ±4.00 diopters.
The IntelliWave 3 , irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100221: INTELLIWAVE3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100221
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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