510(k) Report

510(k) · Cleared

Cleared

Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification

K112373510(k) TraditionalCleared Aug 17, 2012366-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

Innova Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Aug 17, 2012 as substantially equivalent to K073060 (Innova Vision, Inc., 2007) after a 366-day review. Its family tree reaches back 4 generations to 1996.

Decided
Aug 17, 2012
Review
366 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K962804 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2004: 1 other ancestorK962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 1996K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2005K062541 · Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens · Innova Vision, Inc. · 2007K073060 · Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 20071995200020052010
Other ancestors, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor K073060 · Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2007K062541 · Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens · Innova Vision, Inc. · 2007K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2005K962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 19960
  1. Root · 4 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
  2. 3 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
  3. 2 generations backK062541 Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2007
  4. 1 generation backK073060 Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2007
  5. This deviceK112373 Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for…Innova Vision, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerVistakon, Johnson & Johnson Vision Products, Inc.1996—
−3K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.2005—
−2K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc.2007—
−1K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.2007—
0 (this device)K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear…Innova Vision, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
FIG. 1 — Lineage of K112373, 1996–2012Source: 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
*K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
Summary page 1
…Class 11 Predicate Device: Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K073060 from INNOVA VISION INC. Indications for Use Calaview Color (Etafilcon A) So…
Innova Vision, Inc.2007—

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?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
  • None of the 6 ancestors has a 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. 2012, this device’s year, is highlighted.

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?

Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the contact lens may be disinfected using chemical (not heat) disinfection system.

Indications for use as stated in the FDA summary.

More from Innova Vision, Inc.

11 FDA decisions under this applicant name. See the company

  • K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc. · 2024
  • K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022
  • K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009

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/K112373 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112373: Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112373

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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