510(k) · Cleared
ClearedP-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.O.S Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 30, 2025 as substantially equivalent to K221517 (INTEROJO, Inc., 2022) after a 313-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jul 30, 2025
- Review
- 313 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953807 (1996). 11 ancestors in all, the oldest P780007 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
- 4 generations backK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
- 3 generations backK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
- 2 generations backK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
- 1 generation backK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
- This deviceK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953807 | Daily Wear Soft (Hydrophilic) Contact Lens | Stephen A. Dunn, Inc. | 1996 | — |
| −4 | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric… | Stephen A. Dunn, Inc. | 1998 | — |
| −3 | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted… | Poly Vue Technolgies, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…Summary page 5…t/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. 06. Predicate devices Predicate device 510(k) Number: K221517 Device Name: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Cont… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
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. 2025, 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?
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 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…
Read the full statement (133 words)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for
the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00
diopters to -10.00 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.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection,
and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly).
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/K242855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242855
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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