510(k) · Cleared
ClearedNeo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neo Vision Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 7, 2014 as substantially equivalent to K051477 (Mi Gwang Contact Lens Co., Ltd., 2006) after a 53-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.
- Decided
- Oct 7, 2014
- Review
- 53 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051477 (2006). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK051477 Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens…Mi Gwang Contact Lens Co., Ltd. · 2006 · Recalled
- This deviceK142275 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensNeo Vision Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK161098 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses…Joowon Innovation Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK241884 HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK220045 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210609 AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact LensVp Optics · 2021
- Descendant · 2 generations on · 0 of its ownK181656 ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses…Eyemed Technologies S.R.L. · 2019
Most influential descendants
Showing 5 of 5 · See all- K161098ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)Joowon Innovation Co., Ltd. · 2016 · cites it directly2descendants
- K241884HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd. · 2025 · cites it directly0descendants
- K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. · 2022 · 2 generations on0descendants
- K210609AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact LensVp Optics · 2021 · cites it directly0descendants
- K181656ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)Eyemed Technologies S.R.L. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051477 | Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily… | Mi Gwang Contact Lens Co., Ltd. | 2006 | 1 |
| 0 (this device) | K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | Neo Vision Co., Ltd. | 2014 | — |
| +1 | K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | Joowon Innovation Co., Ltd. | 2016 | — |
| +1 | K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | 2025 | — |
| +2 | K220045 | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | Dk Medivision Co., Ltd. | 2022 | — |
| +1 | K210609 | AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens | Vp Optics | 2021 | — |
| +2 | K181656 | ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) | Eyemed Technologies S.R.L. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K051477 | Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear…Summary page 4…Lenses, Soft Contact, Daily Wear CLASSIFICATION NAME Class ll (21 CFR 886.5925) PRODUCT CODE LPL PREDICATE DEVICE K051477 Migwang Comfort 38 Decision Date: 03/10/2006 DEVICE… | 2006 |
What descends from it? (5)
3 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. 2014, 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 Neo Cosmo (Polymacon) Soft (hydrophilic) 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 or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. 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 frequent replacement wear with cleaning, disinfecting and schedule replacement. The lens may be disinfected using a chemical (not heat) lens care system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142275: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142275
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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