510(k) Report

510(k) · Cleared

Cleared

55 SV, Multifocal and Toric (Ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

K051184510(k) TraditionalCleared Jul 1, 200553-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

United Contact Lens, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jul 1, 2005 as substantially equivalent to K941607 (United Contact Lens, Inc., 1994) after a 53-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jul 1, 2005
Review
53 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K941607 (1994). No later device cites it as a predicate yet.

K941607 · Ucl Multifocal Soft Contact Lens · United Contact Lens, Inc. · 19941990199520002005
K941607 · Ucl Multifocal Soft Contact Lens · United Contact Lens, Inc. · 19940
  1. Root · 1 generation backK941607 Ucl Multifocal Soft Contact LensUnited Contact Lens, Inc. · 1994
  2. This deviceK051184 55 SV, Multifocal and Toric (Ocufilcon C) Soft (Hydrophilic) Contact…United Contact Lens, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941607Ucl Multifocal Soft Contact LensUnited Contact Lens, Inc.1994—
0 (this device)K05118455 SV, Multifocal and Toric (Ocufilcon C) Soft (Hydrophilic) Contact Lens for…United Contact Lens, Inc.2005—
FIG. 1 — Lineage of K051184, 1994–2005Source: 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), 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeP92000855 F, Toric 55 and Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lenses
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…ntact (hydrophilic) Contact Lenses Submission number Lenses for Daily Wear for Daily Wear N/A P920008/K941607 Material ocufilcon C ocufilcon C Material classification Hydrophilic Lens Group 4…
*K941607Ucl Multifocal Soft Contact Lens
Summary page 2
…(hydrophilic) Contact Lenses Submission number Lenses for Daily Wear for Daily Wear N/A P920008/K941607 Material ocufilcon C ocufilcon C Material classification Hydrophilic Lens Group 4 Hydro…
United Contact Lens, Inc.1994—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

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 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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. The 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the…

Read the full statement (187 words)

The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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.

The 55 Multifocal (ocufilcon C) 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 and 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.

The 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting 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 disinfecting systems.

Indications for use as stated in the FDA summary.

More from United Contact Lens, Inc.

6 FDA decisions under this applicant name. See the company

  • K941607Ucl Multifocal Soft Contact LensUnited Contact Lens, Inc. · 1994
  • P870079/S003Tresoft Ocufilcon Soft Hydrophilic Contact LensUnited Contact Lens, Inc. · 1990
  • P870079/S005Tresoft Ocufilcon Soft Hydrophilic Contact LensUnited Contact Lens, Inc. · 1990
  • P870079/S002Tresoft Ocufilcon Soft Hydrophilic Contact LensUnited Contact Lens, Inc. · 1989
  • P870079/S001Tresoft Ocufilcon Soft Hydrophilic Contact LensUnited Contact Lens, Inc. · 1989

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/K051184 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051184: 55 SV, Multifocal and Toric (Ocufilcon C) 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/K051184

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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