510(k) Report

510(k) · Cleared

Cleared

Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty 55 UV Multifocal (Methafilcon)

K003526510(k) TraditionalCleared Feb 12, 200188-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

Specialty Ultravision, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Feb 12, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Feb 12, 2001
Review
88 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2011: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK003526 Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for…Specialty Ultravision, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK020855 Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily…Igel Vision Care Pte, Ltd. · 2002
  3. Descendant · 2 generations on · 6 of its ownK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
  4. Descendant · 3 generations on · 5 of its ownK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
  5. Descendant · 4 generations on · 3 of its ownK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
  6. Descendant · 5 generations on · 1 of its ownK102895 One Day Flat PackMenicon Co, Ltd. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12006: 12008: 12011: 12017: 12018: 12019: 1
2002high 1 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K020855Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV…Igel Vision Care Pte, Ltd. · 2002 · cites it directly7descendants
  • K030167Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV BlockerClearlab Pte, Ltd. · 2003 · 2 generations on6descendants
  • K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006 · 3 generations on5descendants
  • K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008 · 4 generations on3descendants
  • K102895One Day Flat PackMenicon Co, Ltd. · 2011 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003526Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily…Specialty Ultravision, Inc.2001—
+1K020855Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel…Igel Vision Care Pte, Ltd.2002—
+2K030167Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV…Clearlab Pte, Ltd.2003—
+3K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.2006—
+4K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd.2008—
+5K102895One Day Flat PackMenicon Co, Ltd.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200610
200810
201110
201710
201810
201910
FIG. 1 — Lineage of K003526, 2001–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K020855Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV…Igel Vision Care Pte, Ltd.20027

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?

  • Of its descendants, K020855 (Igel Vision Care Pte, Ltd., 2002) has gone furthest, with 7 descendants of its own.

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.

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—

More from Specialty Ultravision, Inc.

12 FDA decisions under this applicant name. See the company

  • K011542Specialty D-UV (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty D-UV Multifocal…Specialty Ultravision, Inc. · 2001
  • K011089Speciality 42 UV (Hefilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Speciality 42 UV Toric…Specialty Ultravision, Inc. · 2001
  • K003789Speciality 56 UV (Hefilcon C) Soft (Hydrophillic) Contact Lens for Daily Wear; Speciality 56 UV Toric…Specialty Ultravision, Inc. · 2001
  • K000376Specialty 42 (Hefilcon a) Hydrophilic Contact Lens for Daily Wear, Specialty T-42 Toric (Hefilcon a)…Specialty Ultravision, Inc. · 2000
  • K993580Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily WearSpecialty Ultravision, Inc. · 2000

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/K003526 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003526: Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty 55 UV Multifocal (Methafilcon).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003526

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026