510(k) · Cleared
ClearedIntelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint
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 Jul 3, 2008 as substantially equivalent to K024045 (Contamac, Ltd., 2003) and 1 other predicate after a 190-day review. Its family tree reaches back 3 generations to 1995. 33 later devices descend from it.
- Decided
- Jul 3, 2008
- Review
- 190 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952620 (1995). 4 ancestors in all. 33 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK952620 Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp. · 1995
- 2 generations backK023349 Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for…Contamac, Ltd. · 2002
- 1 generation backK024045 Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for…Contamac, Ltd. · 2003
- This deviceK073621 Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon…Art Optical Contact Lens, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · 2 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 3 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
- Descendant · 2 generations on · 8 of its ownK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · cites it directly32descendants
- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 2 generations on12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 3 generations on11descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · 4 generations on8descendants
- K100244Metro SoftMetro Optics of Austin, Inc. · 2010 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952620 | Optical Blanks: BENZ55G Clear and Visibility Tinted | Benz Research and Development Corp. | 1995 | — |
| −2 | K023349 | Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2002 | — |
| −1 | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2003 | — |
| 0 (this device) | K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear… | Art Optical Contact Lens, Inc. | 2008 | — |
| +1 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +2 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +3 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| +4 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
| +2 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 4 | 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? (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 |
|---|---|---|---|
| * | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Summary page 2…ing predicate devices in terms of contact lens material, intended use and design. Predicate devices include: Contaflex GM3 49% manufactured by Contamac Ltd; K024045 BENZ-G 3X manufactured by Benz Research and Development, K964528 IntelliWavel Device Description: The IntelliWa… | 2003 |
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 2…. Predicate devices include: Contaflex GM3 49% manufactured by Contamac Ltd; K024045 BENZ-G 3X manufactured by Benz Research and Development, K964528 IntelliWavel Device Description: The IntelliWavel, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in… | 1997 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100221 | INTELLIWAVE3 | 2010 | 32 |
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 13 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K100221 (Art Optical Contact Lens, Inc., 2010) has gone furthest, with 32 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. 2008, 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 IntelliWavel, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWavel, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction…
Read the full statement (470 words)
The IntelliWavel, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWavel, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWavel, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWavel, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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.
The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wea are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave2, Multifocal Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of amnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073621: Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073621
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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