510(k) · Cleared
ClearedAQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vp Optics · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 27, 2021 as substantially equivalent to K142275 (Neo Vision Co., Ltd., 2014) after a 57-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Apr 27, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051477 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK051477 Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens…Mi Gwang Contact Lens Co., Ltd. · 2006 · Recalled
- 1 generation backK142275 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensNeo Vision Co., Ltd. · 2014
- This deviceK210609 AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact LensVp Optics · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051477 | Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily… | Mi Gwang Contact Lens Co., Ltd. | 2006 | 1 |
| −1 | K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | Neo Vision Co., Ltd. | 2014 | — |
| 0 (this device) | K210609 | AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens | Vp Optics | 2021 | — |
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 |
|---|---|---|---|
| * | K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensSummary page 5…alent to the following predicate device: * "Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens" By NEO VISION CO., LTD. 510(k) number; K142275 Primary Predicate IV. DEVICE DESCRIPTION The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Len… | 2014 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K142275.
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. 2021, 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 AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia and hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 3.00 diopters or less. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the…
Read the full statement (130 words)
The AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia and hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 3.00 diopters or less. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe the lens for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
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/K210609 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210609: AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210609
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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