510(k) Report

510(k) · Cleared

Cleared

Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear

K963001510(k) TraditionalCleared Mar 11, 1997221-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

Permeable Technologies, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 11, 1997 after a 221-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.

Decided
Mar 11, 1997
Review
221 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1999: 2 descendants cleared2004: 3 descendants cleared2013: 1 descendant cleared2018: 1 descendant cleared2014: 2 descendants cleared2025: 1 descendant cleared2002: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963001 Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for…Permeable Technologies, Inc. · 1997
  2. Descendant · cites it directly · 11 of its ownK971049 Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1997
  3. Descendant · 2 generations on · 5 of its ownK042824 Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004
  4. Descendant · 2 generations on · 4 of its ownK984259 Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear…Cl-Tinters · 1999
  5. Descendant · 3 generations on · 2 of its ownK123973 Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013
  6. Descendant · 3 generations on · 2 of its ownK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997: 11999: 22002: 12004: 32013: 12014: 22018: 12025: 1
1997high 3 (2004) · low 0 (1998)2026

Most influential descendants

Showing 5 of 12 · See all
  • K971049Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Aspect Vision Care, Ltd. · 1997 · cites it directly11descendants
  • K042824Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2004 · 2 generations on5descendants
  • K984259Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Cl-Tinters · 1999 · 2 generations on4descendants
  • K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2013 · 3 generations on2descendants
  • K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963001Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily WearPermeable Technologies, Inc.1997—
+1K971049Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and…Aspect Vision Care, Ltd.1997—
+2K042824Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc.2004—
+2K984259Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and…Cl-Tinters1999—
+3K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation2013—
+3K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199920
200210
200430
201310
201420
201810
202510
FIG. 1 — Lineage of K963001, 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K971049Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Aspect Vision Care, Ltd.199711

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, K971049 (Aspect Vision Care, Ltd., 1997) has gone furthest, with 11 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 Permeable Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K963011Lifestyle Frequency Progressive (Methafilcon a) Multifocal Hydrophilic Contact Lenses for Daily WearPermeable Technologies, Inc. · 1996
  • K963010Lifestyle GP (Telefocon B) Rigid Gas Permeable Multifocal Contact Lens for Daily WearPermeable Technologies, Inc. · 1996
  • K951893Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55 (Ocufilcon D) Ghydrophilic…Permeable Technologies, Inc. · 1995
  • K945981Lifestyle 55 (Methafilcon a) Soft Hydrophilic Contact LensPermeable Technologies, Inc. · 1995
  • K950283Lifestyle 4-Vue (TM) (Polymacon) Hydrophilic Contact LensPermeable Technologies, Inc. · 1995

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/K963001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963001: Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963001

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026