510(k) Report

510(k) · Cleared

Cleared

Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

K994335510(k) TraditionalCleared Mar 20, 200088-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

Wesley Jessen Corp. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 20, 2000 as substantially equivalent to K965052 (Wesley Jessen Corp., 1997) after an 88-day review. Its family tree reaches back 1 generation to 1997.

Decided
Mar 20, 2000
Review
88 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K965052 (1997). No later device cites it as a predicate yet.

Reference device: P830037 · Durasoft (R) 3 for Ext Wear · Alcon Laboratories, Inc. · 1984 · recalledReference device: P850057 · Customeyes (TM) 45L&55L (Bufilcon a) · Ciba Vision Corporation · 1986K965052 · D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses · Wesley Jessen Corp. · 19971996199820002002
K965052 · D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses · Wesley Jessen Corp. · 19970
  1. Root · 1 generation backK965052 D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact LensesWesley Jessen Corp. · 1997
  2. This deviceK994335 Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K965052D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact LensesWesley Jessen Corp.1997—
0 (this device)K994335Prosoft (Phemfilcon) Soft (Hydrophilic) Contact LensWesley Jessen Corp.2000—
FIG. 1 — Lineage of K994335, 1997–2000Source: 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? (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
*K965052D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses
Summary page 3
…roSoft (phemfilcon A) contact lenses are substantially equivalent to marketed DuraSoft® 3UV lenses of the same material as approved under 510(k) premarket notification, K965052, and the tinting process is substantially equivalent to the approved process for CustomEyes (bufilcon A) contact lenses under PMA…
Wesley Jessen Corp.1997—
†P830037Durasoft (R) 3 for Ext WearAlcon Laboratories, Inc.19842
†P850057Customeyes (TM) 45L&55L (Bufilcon a)Ciba Vision Corporation1986—

Also cleared against K965052: 1 other device →

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.
  • 1 other device also cites its predicate K965052.

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?

Spherical ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. Toric ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact…

Read the full statement (172 words)

Spherical

ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

Toric

ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 K965052

1 other device cites the same predicate.

  • K982344Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a)…Wesley Jessen Corp. · 1998

More from Wesley Jessen Corp.

138 FDA decisions under this applicant name. See the company

  • K000439Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical (…Wesley Jessen Corp. · 2000
  • K993935Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a)…Wesley Jessen Corp. · 1999
  • K991000Gentle Touch UV (Netrafilcon a) Soft Contact LensesWesley Jessen Corp. · 1999
  • K991550Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (HYDROPHILIC0…Wesley Jessen Corp. · 1999
  • K982988Precision UV (Vasurfilcon a)Wesley Jessen Corp. · 1999

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/K994335 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994335: Prosoft (Phemfilcon) 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/K994335

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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