510(k) · Cleared
ClearedDream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II (Polymacon) Soft (Hydrophilic) Contact Lens, D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dreamcon Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 17, 2013 as substantially equivalent to K051477 (Mi Gwang Contact Lens Co., Ltd., 2006) after a 222-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Jun 17, 2013
- Review
- 222 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051477 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK051477 Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens…Mi Gwang Contact Lens Co., Ltd. · 2006 · Recalled
- This deviceK123431 Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream…Dreamcon Co., Ltd. · 2013
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) | K123431 | Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II… | Dreamcon Co., Ltd. | 2013 | — |
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 1…Class Il (21 CFR 807.92) November 4, 2012 DreamCon Co., Ltd. 469-1 Sanmak-dong, Yangson-si Gyeongsangnam-do Korea _Albert Rego, Ph.D. Telephone Number: 949-770-8710 K051477 Migwang Comfort 38 Decision Date:03-10-2006 Dream soft contact lenses are hemispherical shape with molded spherical base curv… | 2006 |
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 a recall.
- 4 other devices also cite its predicate K051477.
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. 2013, 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 Dream Color |, Il, and Il (polymacon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 0.50 diopters that 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 eyes.
Eyecare practitioners may prescribe 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/K123431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123431: Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II (Polymacon) Soft (Hydrophilic) Contact Lens, D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123431
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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