510(k) · Cleared
ClearedCooper Prosthetic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 26, 2004 as substantially equivalent to K984259 (Cl-Tinters, 1999) and 1 other predicate after a 48-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Oct 26, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950283 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK950283 Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
- 2 generations backK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
- 1 generation backK984259 Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear…Cl-Tinters · 1999
- This deviceK042435 Cooper ProstheticCooperVision, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950283 | Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact Lens | Permeable Technologies, Inc. | 1995 | — |
| −2 | K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1997 | — |
| −1 | K984259 | Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and… | Cl-Tinters | 1999 | — |
| 0 (this device) | K042435 | Cooper Prosthetic | CooperVision, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K984259 | Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Summary page 3…etic Characteristic UK Lathed Base UK Molded Base Gelflex Lathed Base (New Device) K984259 K010126 Material PaPolymacan Pal mac… | 1999 |
| * | K010126 | Prosthetic, Gelflex Alpha, (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear…Summary page 3…UK Lathed Base UK Molded Base Gelflex Lathed Base (New Device) K984259 K010126 Material PaPolymacan Pal macon Material… | 2001 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K984259.
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 Cooper® Prosthetic (polymacon) Soft (hydrophilic) Contact Lens is indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for management of conditions such as corneal, iris, or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042435: Cooper Prosthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042435
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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