510(k) · Cleared
ClearedAquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegavision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 23, 2013 as substantially equivalent to K020927 (Bausch & Lomb, 2002) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 23, 2013
- Review
- 118 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950283 (1995). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- 2 generations backK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- 1 generation backK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
- This deviceK123973 Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
- 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 |
|---|---|---|---|---|---|
| −3 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| −2 | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1997 | — |
| −1 | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2004 | — |
| 0 (this device) | K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2013 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensSummary page 2…well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA * Soflens Multifocal (Polymacon) Visibility Tinted Contact lens, K 020927 Submitted by Bausch & Lomb Inc. * Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens, K 042824, submitted by Co… | 2002 |
| * | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensSummary page 2…Soflens Multifocal (Polymacon) Visibility Tinted Contact lens, K 020927 Submitted by Bausch & Lomb Inc. * Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens, K 042824, submitted by Cooper Vision Inc. Clinical studies for Aquamx (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact… | 2004 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K132714 (Vision Science Co., Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K020927.
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. 2013, 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?
Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D)or less where the astigmatism does not interfere with…
Read the full statement (141 words)
Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D)or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123973 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123973: Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123973
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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