510(k) · Cleared
ClearedIsens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Science Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 5, 2014 as substantially equivalent to P780007 (CooperVision, Inc., 1979) and 2 other predicates after a 187-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Mar 5, 2014
- Review
- 187 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K950283 (1995). 11 ancestors in all, the oldest P780007 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- 3 generations backK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- 2 generations backK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
- 1 generation backK123973 Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
- This deviceK132714 Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses…Vision Science Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK142384 DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses…Qualimed Srl · 2014
Most influential descendants
Showing 1 of 1 · See all- K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| −3 | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1997 | — |
| −2 | K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2004 | — |
| −1 | K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2013 | — |
| 0 (this device) | K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear… | Vision Science Co., Ltd. | 2014 | — |
| +1 | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 |
|---|---|---|---|
| * | P780007 | Hydron Hydrophilic Contact LensSummary page 2…r and Tinted) are substantially equivalent to the following predicate devices: Predicate devices: * "Biomnedics38" By Coopervision PMA number; P780007 * "Contaflex 38" By Contamac Ltd. 5 10(k) number; K023987 * "Aquatnax" By Pegavision C… | 1979 |
| * | K023987 | Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted…Summary page 2…icate devices: * "Biomnedics38" By Coopervision PMA number; P780007 * "Contaflex 38" By Contamac Ltd. 5 10(k) number; K023987 * "Aquatnax" By Pegavision Corporation 5 10(k) number; K123973 Device Description: The ISENS soft con… | 2003 |
| * | K123973 | Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesSummary page 2…0007 * "Contaflex 38" By Contamac Ltd. 5 10(k) number; K023987 * "Aquatnax" By Pegavision Corporation 5 10(k) number; K123973 Device Description: The ISENS soft contact lenses are hemispherical shells with molded spherical base curves and molded front s… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | 2014 | 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 19 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K142384 (Qualimed Srl, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate P780007.
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. 2014, 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 ISENS (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 .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.…
Read the full statement (239 words)
The ISENS (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 .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ISENS (polymacon) Toric 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 and/or possesses refractive astigmatism not exceeding 4.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132714: Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132714
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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