510(k) · Cleared
ClearedSaview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
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 Mar 11, 2010 as substantially equivalent to K962804 (Vistakon, Johnson & Johnson Vision Products, Inc., 1996) and 1 other predicate after a 176-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Mar 11, 2010
- Review
- 176 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962804 (1996). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- This deviceK092852 Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK132146 Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK172692 Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft…Tangible Science, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK182734 Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic)…Unicon Optical Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2013 · cites it directly2descendants
- K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily…Tangible Science, LLC · 2017 · 2 generations on1descendant
- K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| 0 (this device) | K092852 | Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens… | St. shine Optical Co., Ltd. | 2010 | — |
| +1 | K132146 | Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact… | St. shine Optical Co., Ltd. | 2013 | — |
| +2 | K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Tangible Science, LLC | 2017 | — |
| +3 | K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Unicon Optical Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerSummary page 2…ate devices. 019 The ACUVUE lenses were cleared under 5 10O(k) K962804, and are manufactured by a molding process that uses the etafilcon A material. The dye tinting is different; the lenses are tinte… | 1996 |
| * | K051095 | 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 2…h Reactive Blue #4, where the Saview 58 UV lenses are tinted with Pigment Blue 15. The 55 UV, 55 UV Tonec, 55 UV Multifocal Soft Contact Lenses are cleared under 510(k) K051095, and are selected as predicate devices because although they are molded from a different material, they are tinted with the same… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132146 | Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens… | 2013 | 2 |
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?
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. 2010, 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 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.…
Read the full statement (249 words)
The Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. Saview 58 UV Toric lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092852: Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092852
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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