510(k) · Cleared
ClearedPOLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
INTEROJO, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 4, 2022 as substantially equivalent to K020608 (Poly Vue Technolgies, Inc., 2002) and 1 other predicate after a 132-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Oct 4, 2022
- Review
- 132 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953807 (1996). 10 ancestors in all, the oldest P780007 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
- 3 generations backK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
- 2 generations backK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
- 1 generation backK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
- This deviceK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953807 | Daily Wear Soft (Hydrophilic) Contact Lens | Stephen A. Dunn, Inc. | 1996 | — |
| −3 | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric… | Stephen A. Dunn, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon)… | INTEROJO, Inc. | 2022 | — |
| +1 | 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 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020608 | HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Summary page 5…, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully cast- molded lens)” By PolyVue Technologies, Inc. 510(k) number; K020608 Primary Predicate “Clalen 54 (hioxifilcon D) & Clalen 58 (hioxifilcon A) Soft Contact Lenses” By… | 2002 |
| * | K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…Summary page 5…Primary Predicate “Clalen 54 (hioxifilcon D) & Clalen 58 (hioxifilcon A) Soft Contact Lenses” By Interojo, Inc. 510(k) number; K153766 Reference Predicate IV. DEVICE DESCRIPTION The POLYVUE and POLYVUE COLOR (polymacon) Soft (hydrophilic) Conta… | 2016 |
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 |
|---|---|---|---|
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | 2025 | 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 26 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K242855 (E.O.S Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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 POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses 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 lenses are available…
Read the full statement (198 words)
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses 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 lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The POLYVUE and POLYVUE COLOR (polymacon) ASPHERIC TORIC Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lenses may be worn by persons who exhibit refractive astigmatism of 5.00 diopters or less. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program 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 as stated in the FDA summary.
https://510kreport.com/device/K221517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221517: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221517
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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