510(k) · Cleared
ClearedContaflex 38 (Polymacon) 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 26, 2003 as substantially equivalent to K961103 (Benz Research and Development Corp., 1996) after an 86-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Feb 26, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961103 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961103 Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 1996
- This deviceK023987 Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear…Contamac, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK132714 Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses…Vision Science Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK142384 DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses…Qualimed Srl · 2014
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 |
|---|---|---|---|---|---|
| −1 | K961103 | Benz 38 Clear & with Blue Visibility Tint | Benz Research and Development Corp. | 1996 | — |
| 0 (this device) | K023987 | Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and… | Contamac, Ltd. | 2003 | — |
| +1 | K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear… | Vision Science Co., Ltd. | 2014 | — |
| +2 | K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and… | Qualimed Srl | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K961103 | Benz 38 Clear & with Blue Visibility TintSummary page 2…edicate device: “BENZ 38” Manufactured/distributed by Benz Research and Development. 5 1O(k) number; K961103 Device Description: The CONTAFLEX 38 Spherical Soft Contact Lenses are fabricated from polymacon, which in the dry (unhydrated… | 1996 |
| † | K973597 | AL-47 (Isofilcon) Soft (Spherical) Daily Wear Contact Lens | 1997 |
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 |
|---|---|---|---|
| K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and… | 2014 | 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?
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 38 (polymacon) 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 (104 words)
The CONTAFLEX 38 (polymacon) 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 frequendplanned 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/K023987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023987: Contaflex 38 (Polymacon) 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/K023987
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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