510(k) · Cleared
Recalled · Class II · 2017See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The See Clear Company, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 2, 2011 as substantially equivalent to K051477 (Mi Gwang Contact Lens Co., Ltd., 2006) after a 173-day review. Its family tree reaches back 1 generation to 2006. It has been recalled once.
- Decided
- Nov 2, 2011
- Review
- 173 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 1
- 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 deviceK111345 See Clear Soft Contact Lens, See Clear Color Soft Contact Lens…The See Clear Company, Inc. · 2011
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) | K111345 | See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft… | The See Clear Company, Inc. | 2011 | — |
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 2…ontact Lens Co. CompanyLtd. 510(k) Number KI 11345 K05 1477 Daily wear correction of Daily wear correction of… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2017 | Class II | Z-1404-2017 | Device Design | Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates. |
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. 2011, 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 See Clear Spherical Soft Contact Lenses (polymnacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person 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…
Read the full statement (112 words)
The See Clear Spherical Soft Contact Lenses (polymnacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person 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.
Eye care 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 as stated in the FDA summary.
https://510kreport.com/device/K111345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111345: See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft 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/K111345
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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