510(k) · Cleared
ClearedCalaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Vision, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Nov 29, 2007 as substantially equivalent to K062541 (Innova Vision, Inc., 2007) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Nov 29, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962804 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 2 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
- 1 generation backK062541 Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2007
- This deviceK073060 Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK112373 Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for…Innova Vision, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear ModificationInnova Vision, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −2 | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2005 | — |
| −1 | K062541 | Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | 2007 | — |
| 0 (this device) | K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2007 | — |
| +1 | K112373 | Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear… | Innova Vision, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 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 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062541 | Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensSummary page 1…s (Etafilcon A) Soft ACUVUE 2 colours Brand (Etafilcon A) (hydrophilic) Contact Lens for Daily Wear Contact Lens cleared via K010114 cleared via K062541 INNOVA VISION INC. Johnson & Johnson Co. USA. Indications for Use Calaview (Etafilc… | 2007 |
| * | K010114 | Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance…Summary page 1…vice: Calaview Colors (Etafilcon A) Soft ACUVUE 2 colours Brand (Etafilcon A) (hydrophilic) Contact Lens for Daily Wear Contact Lens cleared via K010114 cleared via K062541 INNOVA VISION INC. Johnson & Johnson Co. USA. Indications… | 2001 |
| † | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112373 | Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification | 2012 | 0 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112373 (Innova Vision, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MVN
2in 2020
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear 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 eyecare 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.
https://510kreport.com/device/K073060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073060: Calaview (Etafilcon a) Soft (Hydrophilic) 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/K073060
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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