510(k) · Cleared
ClearedHD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poly Vue Technolgies, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 20, 2001 as substantially equivalent to K982110 (Optech, Inc., 1998) and 2 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 20, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953807 (1996). 5 ancestors in all, the oldest P780007 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
- 1 generation backK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
- This deviceK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK142766 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2002 · cites it directly2descendants
- K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc. · 2022 · 2 generations on1descendant
- K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025 · 3 generations on0descendants
- K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953807 | Daily Wear Soft (Hydrophilic) Contact Lens | Stephen A. Dunn, Inc. | 1996 | — |
| −1 | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric… | Stephen A. Dunn, Inc. | 1998 | — |
| 0 (this device) | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted… | Poly Vue Technolgies, Inc. | 2001 | — |
| +1 | K020608 | HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully… | Poly Vue Technolgies, Inc. | 2002 | — |
| +2 | K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon)… | INTEROJO, Inc. | 2022 | — |
| +3 | K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | 2025 | — |
| +1 | K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | INTEROJO, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K982110 | Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact…Summary page 2…evices: The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are substantially equivalent to the following predicate devices: Predicate devices: e “PolyVue” (polymacon) K982110, approval by Optech, Inc. e “PolyVue Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. e “Hydron B… | 1998 |
| * | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and…Summary page 2…alent to the following predicate devices: Predicate devices: e “PolyVue” (polymacon) K982110, approval by Optech, Inc. e “PolyVue Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. e “Hydron Biomedics” (polymacon) P780007, approval by Ocular Sciences, Inc. Device Descriptio… | 1998 |
| * | P780007 | Hydron Hydrophilic Contact LensSummary page 2…polymacon) K982110, approval by Optech, Inc. e “PolyVue Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. e “Hydron Biomedics” (polymacon) P780007, approval by Ocular Sciences, Inc. Device Description: The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are hemispherical she… | 1979 |
| † | K002099 | S38 (Polymacon) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily… | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K020608 (Poly Vue Technolgies, Inc., 2002) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K982110.
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 HD (polymacon) Aspheric 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 1.50 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…
Read the full statement (312 words)
The HD (polymacon) Aspheric 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 1.50 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 HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The PV (polymacon) Multi-Aspheric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 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 PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013220: HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013220
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026