510(k) · Cleared
ClearedTREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dk Medivision Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 5, 2022 as substantially equivalent to K132854 (Yung Sheng Optical Co., Ltd., 2013) and 1 other predicate after a 212-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 5, 2022
- Review
- 212 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960926 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 2 generations backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- 1 generation backK132854 Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2013
- This deviceK220045 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −2 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| −1 | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for… | Yung Sheng Optical Co., Ltd. | 2013 | — |
| 0 (this device) | K220045 | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | Dk Medivision Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K132854 | Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 5…owing predicate device(s): ƒ “Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens” By YUNG SHENG OPTICAL 510(k) number; K132854 Primary Predicate ƒ “ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses (Tinted/Color)”… | 2013 |
| * | K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)Summary page 5…edicate ƒ “ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses (Tinted/Color)” By JOOWON INNOVATION CO., LTD. 510(k) number; K161098 Reference Predicate IV. DEVICE DESCRIPTION The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted,… | 2016 |
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 26 years and passes through 4 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K132854.
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. 2022, 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 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 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 eye…
Read the full statement (110 words)
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 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 eye care professionals may prescribe the lens for single use daily disposable or daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220045: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220045
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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