510(k) · Cleared
ClearedHorizon 38 (Clear) and Horizon 38 Westint (Tinted)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westcon Contact Lens Co., Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 26, 2002 as substantially equivalent to K963837 (Westcon Contact Lens Co., Inc., 1996) after a 36-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 26, 2002
- Review
- 36 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963837 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963837 Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily…Westcon Contact Lens Co., Inc. · 1996
- This deviceK023530 Horizon 38 (Clear) and Horizon 38 Westint (Tinted)Westcon Contact Lens Co., Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963837 | Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear… | Westcon Contact Lens Co., Inc. | 1996 | — |
| 0 (this device) | K023530 | Horizon 38 (Clear) and Horizon 38 Westint (Tinted) | Westcon Contact Lens Co., Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K963837 | Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens…Summary page 2…. 5.0 Substantially Equivalent To: Westcon will be claiming equivalency to our own contact lenses that are current11 FDA approved in 5 1 O(k) K963837. 6.0 Summary of Safety and Effectiveness W-3 8 (polymacon) lens blanks were subjected to leachability studies and… | 1996 |
| † | K954524 | W-55 (Methafilon a) Contact Lens | 1996 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K963837.
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 Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.
The lenses may be disinfected using either a heat or chemical system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023530: Horizon 38 (Clear) and Horizon 38 Westint (Tinted).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023530
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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