510(k) Report

510(k) · Cleared

Recalled · Class III · 2017

Biofinity (Comfilcon a) Soft Contact Lens

K052560510(k) TraditionalCleared Dec 6, 200581-day reviewClass II21 CFR 886.5925Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CooperVision, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 6, 2005 as substantially equivalent to K970746 (Ciba Vision Corporation, 1997) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1981. 74 later devices descend from it. It has been recalled once.

Decided
Dec 6, 2005
Review
81 days
Class
Class II
Product code
LPL
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to P810005 (1981). 6 ancestors in all. 74 later devices descend from it, 15 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1984: 1 other ancestor2001: 1 other ancestor2016: 7 descendants cleared2010: 4 descendants cleared2012: 5 descendants cleared2008: 1 descendant cleared2015: 3 descendants cleared2025: 5 descendants cleared2009: 1 descendant cleared2021: 5 descendants cleared2011: 3 descendants cleared2013: 2 descendants cleared2019: 4 descendants cleared2023: 3 descendants cleared2014: 1 descendant cleared2024: 10 descendants cleared2017: 4 descendants cleared2022: 2 descendants cleared2026: 5 descendants cleared2020: 3 descendants cleared2018: 6 descendants clearedP810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997K020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 15 descendants2 generations forward: 23 descendants3 generations forward: 15 descendants4 generations forward: 9 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 4 descendants K033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 19810+5
  1. Root · 4 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
  2. 3 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
  3. 2 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
  4. 1 generation backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
  5. This deviceK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005
  6. Descendant · cites it directly · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
  7. Descendant · cites it directly · 14 of its ownK071736 Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · Recalled
  8. Descendant · cites it directly · 12 of its ownK141348 Visco Soft Contact LensVisco Vision, Inc. · 2015
  9. Descendant · 2 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
  10. Descendant · 3 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 42011: 32012: 52013: 22014: 12015: 32016: 72017: 42018: 62019: 42020: 32021: 52022: 22023: 32024: 102025: 52026: 5
2008high 10 (2024) · low 1 (2008)2026

Most influential descendants

Showing 5 of 74 · See all
  • K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · cites it directly32descendants
  • K071736Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2008 · cites it directly14descendants
  • K141348Visco Soft Contact LensVisco Vision, Inc. · 2015 · cites it directly12descendants
  • K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 2 generations on12descendants
  • K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4P810005Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care1981—
−3K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation1997—
−2K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation2002—
−1K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal…Ciba Vision Corporation20041
0 (this device)K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.2005—
+1K100221INTELLIWAVE3Art Optical Contact Lens, Inc.2010—
+1K071736Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc.20082
+1K141348Visco Soft Contact LensVisco Vision, Inc.2015—
+2K142641Intelliwave4Art Optical Contact Lens, Inc.2015—
+3K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens…Art Optical Contact Lens, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201040
201130
201250
201320
201410
201530
201670
201740
201860
201940
202030
202150
202220
202330
2024100
202550
202650
FIG. 1 — Lineage of K052560, 1981–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K970746SEE3 (Lotrafilcon a) Soft Contact Lens
Summary page 2
…fected using a chemical or hydrogen peroxide disinfecting systems. 7. Predicate Device(s) CIBA Vision SEE3TM (lotrafilcon A) Soft Contact Lenses 1K970746] CIBA Vision O 2OPTIX IM (Iotrafilcoi B) Soft Contact Lenses [K0339191…
Ciba Vision Corporation1997—
*K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs
Summary page 2
…7. Predicate Device(s) CIBA Vision SEE3TM (lotrafilcon A) Soft Contact Lenses 1K970746] CIBA Vision O 2OPTIX IM (Iotrafilcoi B) Soft Contact Lenses [K0339191 - 2 - C__pe…
Ciba Vision Corporation20041

Also cleared against K970746: 3 other devices →

What descends from it? (74)

See all 74

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

NumberDeviceApplicantDecidedDescendants
K100221INTELLIWAVE3Art Optical Contact Lens, Inc.201032
K071736Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc.200814
K141348Visco Soft Contact LensVisco Vision, Inc.201512
K100244Metro SoftMetro Optics of Austin, Inc.20108
K160212ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc.20165
K210436Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30…Alcon Laboratories, Inc.20214
K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20252
K100456Cvue Advanced DefinitiveUnilens Corp., USA20102
K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101
K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc.20091

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 1, 2017Class IIIZ-0691-2018Employee errorThe firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K100221 (Art Optical Contact Lens, Inc., 2010) has gone furthest, with 32 descendants of its own.
  • 3 other devices also cite its predicate K970746.

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 AND ASPHERICAL: BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. TORIC: BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or…

Read the full statement (187 words)

SPHERICAL AND ASPHERICAL:

BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

TORIC:

BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MULTIFOCAL:

BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The BIOFINITY (comfilcon A), BIOFINITY Toric (comfilcon A) and BIOFINITY Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Indications for use as stated in the FDA summary.

Also cleared against K970746

3 other devices cite the same predicate.

  • K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc. · 2009
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008
  • K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002

More from CooperVision, Inc.

671 FDA decisions under this applicant name. See the company

  • P080011/S204Biofinity (Comfilcon a)CooperVision, Inc. · 2026
  • P080011/S203comfilcon A Soft (Hydrophilic) Contact Lenses for Extended WearCooperVision, Inc. · 2026
  • P080011/S202comflicon A Soft (Hydrophilic) Contact Lenses for Extended WearCooperVision, Inc. · 2026
  • P080011/S201Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity…CooperVision, Inc. · 2026
  • P080011/S200Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity…CooperVision, Inc. · 2026

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/K052560 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052560: Biofinity (Comfilcon a) Soft 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/K052560

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