510(k) Report

510(k) · Cleared

Cleared

Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact

K010636510(k) SpecialCleared Mar 23, 200118-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

Ciba Vision Corporation · MVN Lens, Contact, (Disposable)

Cleared on Mar 23, 2001 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Mar 23, 2001
Review
18 days
Class
Class II
Product code
MVN
Recalls
None
Predicates
0

24 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2003: 1 descendant cleared2009: 1 descendant cleared2018: 4 descendants cleared2013: 2 descendants cleared2019: 2 descendants cleared2016: 4 descendants cleared2020: 3 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK010636 Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus…Ciba Vision Corporation · 2001
  2. Descendant · cites it directly · 21 of its ownK050213 Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005
  3. Descendant · cites it directly · 12 of its ownK033701 Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives…Ciba Vision Corporation · 2003
  4. Descendant · cites it directly · 11 of its ownK050065 Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · Recalled
  5. Descendant · 2 generations on · 10 of its ownK083216 Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  6. Descendant · 2 generations on · 8 of its ownK123484 Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal…St. shine Optical Co., Ltd. · 2013

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2003: 12005: 22009: 12013: 22016: 42018: 42019: 22020: 32021: 12022: 12024: 12025: 12026: 1
2003high 4 (2016) · low 0 (2004)2026

Most influential descendants

Showing 5 of 24 · See all
  • K050213Freshlook One-Day Color Contact LensCiba Vision Corporation · 2005 · cites it directly21descendants
  • K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation · 2003 · cites it directly12descendants
  • K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation · 2005 · cites it directly11descendants
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009 · 2 generations on10descendants
  • K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft…St. shine Optical Co., Ltd. · 2013 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010636Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies…Ciba Vision Corporation2001—
+1K050213Freshlook One-Day Color Contact LensCiba Vision Corporation2005—
+1K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft…Ciba Vision Corporation2003—
+1K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation20051
+2K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation2009—
+2K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon…St. shine Optical Co., Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200520
200910
201320
201640
201840
201920
202030
202110
202210
202410
202510
202610
FIG. 1 — Lineage of K010636, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MVN? 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 MVN device

  1. #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K050213Freshlook One-Day Color Contact LensCiba Vision Corporation200521
K033701Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact…Ciba Vision Corporation200312
K050065Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesCiba Vision Corporation200511

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, K050213 (Ciba Vision Corporation, 2005) has gone furthest, with 21 descendants of its own.

How does its category compare?

All MVN devices

MVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVN

2in 2020

2007: 12008: 22011: 12013: 12015: 22020: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVN

Too few MVN 510(k)s in any year since 2007 to give a median.

Recalls per year · MVN

2in 2013

2009: 12011: 12013: 22026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MVN

22in 2025

2010: 32011: 92012: 252013: 352014: 202015: 102016: 182017: 232018: 322019: 342020: 322021: 242022: 182023: 242024: 252025: 22
2007high 35 (2013) · low 0 (2007)2025

MAUDE reports naming product code MVN, 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
20071—00
20082—00
20090—10
20100—03
20111—19
20120—025
20131—235
20140—020
20152—010
20160—018
20170—023
20180—032
20190—034
20202—032
20210—024
20220—018
20230—024
20240—025
20250—022
20261—1—

More from Ciba Vision Corporation

210 FDA decisions under this applicant name. See the company

  • K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation · 2014
  • K123994Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus MultifocalCiba Vision Corporation · 2013
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal ToricCiba Vision Corporation · 2012
  • K083216Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesCiba Vision Corporation · 2009
  • K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation · 2008

Recent decisions in MVN

The MVN category page

  • K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily…HOYA Lamphun, Ltd. · 2026
  • K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc. · 2020
  • K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP…Alcon Laboratories, Inc. · 2020
  • K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV…Yung Sheng Optical Co., Ltd. · 2015
  • K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd. · 2015

https://510kreport.com/device/K010636 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010636: Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010636

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