510(k) · Cleared
ClearedPolyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optech, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 6, 1998 as substantially equivalent to K963764 (Specialty Ultravision, Inc., 1997) after a 143-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 143 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963764 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963764 Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSpecialty Ultravision, Inc. · 1997
- This deviceK982110 Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal…Optech, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK013220 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 · 2 generations on · 0 of its ownK142766 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2001 · cites it directly4descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963764 | Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear | Specialty Ultravision, Inc. | 1997 | — |
| 0 (this device) | K982110 | Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal… | Optech, Inc. | 1998 | — |
| +1 | 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 | — |
| +2 | K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | INTEROJO, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K963764 | Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSummary page 1…erical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibllity tinted) Is the same lens - material that received rnerkating clearance pursuant to K963764 for Speciaity UltraVision, Inc. This lens conforms to and Is substantially equivalent to spherical, aspherlcal, presbyopic and as… | 1997 |
What descends from it? (5)
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?
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 PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in aphakic and non-aphakic persons with non-diseased eyes.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
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/K982110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982110: Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982110
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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