510(k) · Cleared
ClearedHD/HDT, (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 May 16, 2002 as substantially equivalent to K013220 (Poly Vue Technolgies, Inc., 2001) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- May 16, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K953807 (1996). 6 ancestors in all, the oldest P780007 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
- 2 generations backK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
- 1 generation backK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
- This deviceK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025
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 | K953807 | Daily Wear Soft (Hydrophilic) Contact Lens | Stephen A. Dunn, Inc. | 1996 | — |
| −2 | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric… | Stephen A. Dunn, Inc. | 1998 | — |
| −1 | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted… | Poly Vue Technolgies, Inc. | 2001 | — |
| 0 (this device) | K020608 | HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully… | Poly Vue Technolgies, Inc. | 2002 | — |
| +1 | K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon)… | INTEROJO, Inc. | 2022 | — |
| +2 | K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Summary page 2…ION ~ A new indication of “early presbyopia” up to 1.25 diopters is being added to the previously cleared HD/HDT, (polymacon) Soft Contact Lens for Daily Wear reference K013220. Equivalent Devices: The HD/HDT, (polymacon) Soft Contact Lenses are substantially equivalent to the following predicate device… | 2001 |
| * | K982110 | Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact…Summary page 2…tially equivalent to the following predicate devices: Predicate devices: e “HD/HDT” (polymacon) K013220, approval by PolyVue Technologies, Inc. e “PolyVue” (polymacon) K982110, approval by Optech, Inc. e “PolyVue” Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. Device Des… | 1998 |
| * | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and…Summary page 2…” (polymacon) K013220, approval by PolyVue Technologies, Inc. e “PolyVue” (polymacon) K982110, approval by Optech, Inc. e “PolyVue” Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. Device Description: The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with… | 1998 |
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 |
|---|---|---|---|
| K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft… | 2022 | 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 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K221517 (INTEROJO, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K013220.
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 not aphakic persons with non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. 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…
Read the full statement (182 words)
The HD (polymacon) Aspheric 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 early presbyopia up to 1.25 diopters. 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, possesses refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. 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/K020608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020608: HD/HDT, (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/K020608
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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