510(k) · Cleared
Recalled · 2006Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mi Gwang Contact Lens Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 10, 2006 after a 280-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled once.
- Decided
- Mar 10, 2006
- Review
- 280 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK051477 Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens…Mi Gwang Contact Lens Co., Ltd. · 2006
- Descendant · cites it directly · 5 of its ownK142275 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 · 2 of its ownK141699 Vassen ColorVassen Co., Ltd. · 2014
- Descendant · 2 generations on · 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 ownK220143 BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensShenzhen Dashicheng Optical Technology Co., Ltd. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K142275Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact LensNeo Vision Co., Ltd. · 2014 · cites it directly5descendants
- K161098ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)Joowon Innovation Co., Ltd. · 2016 · cites it directly2descendants
- K141699Vassen ColorVassen Co., Ltd. · 2014 · cites it directly2descendants
- K241884HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K220143BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact LensShenzhen Dashicheng Optical Technology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051477 | Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily… | Mi Gwang Contact Lens Co., Ltd. | 2006 | — |
| +1 | 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 | K141699 | Vassen Color | Vassen Co., Ltd. | 2014 | — |
| +2 | K241884 | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) | Hunan Haipuming Technology Co., Ltd. | 2025 | — |
| +2 | K220143 | BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens | Shenzhen Dashicheng Optical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Advantage 38 (polymacon) Named without a submission number | |
| * | — | ContaFlex 38 (polymacon) Named without a submission number |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | 2014 | 5 |
| K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | 2016 | 2 |
| K141699 | Vassen Color | 2014 | 2 |
| K123431 | Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II (Polymacon)… | 2013 | 0 |
| K111345 | See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact Lens | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2006 | Not classified | Z-1257-06 | Other | Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142275 (Neo Vision Co., Ltd., 2014) has gone furthest, with 5 descendants of its own.
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 MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color…
Read the full statement (176 words)
The MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MiGwang Comfort 38 (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe any of the above lenses 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.
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/K051477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051477: Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051477
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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