510(k) Report

510(k) · Cleared

Cleared

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

K240477510(k) TraditionalCleared Jul 1, 2024132-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

St. shine Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jul 1, 2024 as substantially equivalent to K042275 (Vistakon, 2004) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.

Decided
Jul 1, 2024
Review
132 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K042275 (2004). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2025: 1 descendant cleared2026: 1 descendant clearedK042275 · Vistakon (Senofilcon a) Soft Contact Lens · Vistakon · 2004 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K042275 · Vistakon (Senofilcon a) Soft Contact Lens · Vistakon · 2004 · recalled0
  1. Root · 1 generation backK042275 Vistakon (Senofilcon a) Soft Contact LensVistakon · 2004 · Recalled
  2. This deviceK240477 Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2024
  3. Descendant · cites it directly · 1 of its ownK250364 Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft…St. shine Optical Co., Ltd. · 2025
  4. Descendant · 2 generations on · 0 of its ownK254269 Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft…St. shine Optical Co., Ltd. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2025 · cites it directly1descendant
  • K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K042275Vistakon (Senofilcon a) Soft Contact LensVistakon20043
0 (this device)K240477Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd.2024—
+1K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd.2025—
+2K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
202610
FIG. 1 — Lineage of K240477, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K042275Vistakon (Senofilcon a) Soft Contact Lens
Summary page 5
…ct Code: LPL, MVN Panel: Ophthalmic Predicate Devices:  VISTAKON (SENOFILCON A) SOFT CONTACT LENS - K042275  55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses…
Vistakon20043
*K05109555 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
Summary page 5
…FILCON A) SOFT CONTACT LENS - K042275  55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses - K051095 Description of Devices: Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Vis…
Optical Connection, Inc.2005—

Also cleared against K042275: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd.20251

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K250364 (St. shine Optical Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K042275.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

Saview SH 38 UV (Senofilcon A) Visibility Tinted 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 who may have 1.00D of astigmatism or less does not interfere with visual acuity. Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive…

Read the full statement (274 words)

Saview SH 38 UV (Senofilcon A) Visibility Tinted 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 who may have 1.00D of astigmatism or less does not interfere with visual acuity.

Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted 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 who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear or frequent replacement wear. Eye care practitioners may prescribe the lens for daily disposable wear, or for frequent replacement wear.

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K042275

3 other devices cite the same predicate.

  • K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. · 20211 recall
  • K200243ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020
  • K180299ACUVUE OASYS (senofilcon A) with Photochromic AdditiveJohnson & Johnson Vision Care, Inc. · 2018

More from St. shine Optical Co., Ltd.

11 FDA decisions under this applicant name. See the company

  • K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38…St. shine Optical Co., Ltd. · 2026
  • K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38…St. shine Optical Co., Ltd. · 2025
  • K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric…St. shine Optical Co., Ltd. · 2016
  • K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric…St. shine Optical Co., Ltd. · 2013
  • K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. · 2013

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K240477 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240477: Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted 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/K240477

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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