510(k) · Cleared
ClearedContaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contamac, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 14, 2003 as substantially equivalent to K964528 (Benz Research and Development Corp., 1997) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1995. 34 later devices descend from it.
- Decided
- Feb 14, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952620 (1995). 3 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952620 Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp. · 1995
- 1 generation backK023349 Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for…Contamac, Ltd. · 2002
- This deviceK024045 Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for…Contamac, Ltd. · 2003
- Descendant · cites it directly · 33 of its ownK073621 Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon…Art Optical Contact Lens, Inc. · 2008
- Descendant · 2 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · 3 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 4 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- Descendant · 5 generations on · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Art Optical Contact Lens, Inc. · 2008 · cites it directly33descendants
- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 2 generations on32descendants
- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 3 generations on12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 4 generations on11descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952620 | Optical Blanks: BENZ55G Clear and Visibility Tinted | Benz Research and Development Corp. | 1995 | — |
| −1 | K023349 | Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2002 | — |
| 0 (this device) | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2003 | — |
| +1 | K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear… | Art Optical Contact Lens, Inc. | 2008 | — |
| +2 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +3 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +4 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| +5 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 2…ce Predicate devices: “BENZG3X’ manufactweddistributed by Benz Research and Development (hioxifikon B) 5 1O(k) number; K964528 “CONTAFLEX GM3 58%” manufactured by Contamac Ltd. (acofilcon A)… | 1997 |
| * | K023349 | Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and… Cleared while this submission was under review | 2002 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue… | 2008 | 33 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073621 (Art Optical Contact Lens, Inc., 2008) has gone furthest, with 33 descendants of its own.
- 10 other devices also cite its predicate K964528.
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.
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 CONTAFLEX GM3 58 (acofilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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 lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may…
Read the full statement (106 words)
The CONTAFLEX GM3 58 (acofilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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 lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequendplanned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for fiequentlplanned 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/K024045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024045: Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024045
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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