510(k) · Cleared
ClearedSaview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. shine Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 21, 2016 as substantially equivalent to K123484 (St. shine Optical Co., Ltd., 2013) and 1 other predicate after a 63-day review. Its family tree reaches back 5 generations to 1983. 7 later devices descend from it.
- Decided
- Oct 21, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P820021 (1983). 14 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- 4 generations backK963487 Dailies (Nelfilcon a) One-Day Soft Contact LensCiba Vision Corporation · 1996 · Recalled
- 3 generations backK992446 Dailies (Nelfilcon a) One-DayCiba Vision Johns Creek Mfg. · 1999
- 2 generations backK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
- 1 generation backK123484 Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal…St. shine Optical Co., Ltd. · 2013
- This deviceK162317 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
- Descendant · 3 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK180322 Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · cites it directly4descendants
- K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 2 generations on2descendants
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 3 generations on1descendant
- K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018 · cites it directly1descendant
- K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| −4 | K963487 | Dailies (Nelfilcon a) One-Day Soft Contact Lens | Ciba Vision Corporation | 1996 | 1 |
| −3 | K992446 | Dailies (Nelfilcon a) One-Day | Ciba Vision Johns Creek Mfg. | 1999 | — |
| −2 | K050213 | Freshlook One-Day Color Contact Lens | Ciba Vision Corporation | 2005 | — |
| −1 | K123484 | Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon… | St. shine Optical Co., Ltd. | 2013 | — |
| 0 (this device) | K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens… | St. shine Optical Co., Ltd. | 2016 | — |
| +1 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
| +2 | K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2021 | — |
| +3 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
| +1 | K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision, Inc. | 2018 | — |
| +4 | K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K123484 | Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft…Summary page 4…Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K123484 and Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal(methafilcon A) Soft (Hydrophilic) Cont… | 2013 |
| * | K121201 | Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensSummary page 4…and Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal(methafilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K121201. Page 1 of 5 K162317 510(k) Summary Description of Dev… | 2012 |
What descends from it? (7)
2 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?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K200296 (Pegavision Corporation, 2020) has gone furthest, with 4 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. 2016, 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 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye. The Saview-Colors Aqua 42 UV Toric…
Read the full statement (257 words)
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.
Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) 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/K162317
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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