510(k) Report

510(k) · Cleared

Cleared

Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear

K963764510(k) TraditionalCleared Jan 30, 1997133-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 Jan 30, 1997 after a 133-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Jan 30, 1997
Review
133 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1998: 1 descendant cleared2001: 1 descendant cleared2002: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963764 Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSpecialty Ultravision, Inc. · 1997
  2. Descendant · cites it directly · 5 of its ownK982110 Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal…Optech, Inc. · 1998
  3. Descendant · 2 generations on · 4 of its ownK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
  4. Descendant · 2 generations on · 2 of its ownK020608 HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and…Poly Vue Technolgies, Inc. · 2002
  5. Descendant · 3 generations on · 1 of its ownK221517 POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR…INTEROJO, Inc. · 2022
  6. Descendant · 4 generations on · 0 of its ownK242855 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12001: 12002: 12015: 12022: 12025: 1
1998high 1 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K982110Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact…Optech, Inc. · 1998 · cites it directly5descendants
  • K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2001 · 2 generations on4descendants
  • K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc. · 2002 · 2 generations on2descendants
  • K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc. · 2022 · 3 generations on1descendant
  • K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963764Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSpecialty Ultravision, Inc.1997—
+1K982110Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal…Optech, Inc.1998—
+2K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted…Poly Vue Technolgies, Inc.2001—
+2K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.2002—
+3K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon)…INTEROJO, Inc.2022—
+4K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200110
200210
201510
202210
202510
FIG. 1 — Lineage of K963764, 1997–2025Source: 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? (1)

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
*—Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear
Named without a submission number
—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982110Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact…Optech, Inc.19985
K983160Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily WearHydron, Ltd.19990

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, K982110 (Optech, Inc., 1998) has gone furthest, with 5 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—

What is it indicated for?

The Specialty T (ocufilcon A) Soft (hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

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

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
  • K003526Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty 55 UV Multifocal…Specialty Ultravision, Inc. · 2001
  • K000376Specialty 42 (Hefilcon a) Hydrophilic Contact Lens for Daily Wear, Specialty T-42 Toric (Hefilcon a)…Specialty 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/K963764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963764: Specialty T Toric (Ocufilcon a) 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/K963764

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