510(k) · Cleared
ClearedCalaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 7, 2007 as substantially equivalent to K010114 (Johnson & Johnson Vision Care, Inc., 2001) and 1 other predicate after a 281-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 7, 2007
- Review
- 281 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962804 (1996). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 1 generation backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
- This deviceK062541 Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK073060 Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK112373 Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for…Innova Vision, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −1 | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2005 | — |
| 0 (this device) | K062541 | Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens | Innova Vision, Inc. | 2007 | — |
| +1 | K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2007 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 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 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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K010114 | Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance…Summary page 1…ACUVUE 2 colours Brand Discon (Etafilcon A) Soft (hydrophilic) (Etafilcon A) Contact Lens cleared Contact Lens for Daily Wear cleared via K010114 Johnson & Johnson via K051129 from Innova Vision Inc., Co. USA. Taiwan.… | 2001 |
| * | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 1…Discon (Etafilcon A) Soft (hydrophilic) (Etafilcon A) Contact Lens cleared Contact Lens for Daily Wear cleared via K010114 Johnson & Johnson via K051129 from Innova Vision Inc., Co. USA. Taiwan. Indications… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | 2007 | 1 |
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 8.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073060 (Innova Vision, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K010114.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
Calaview Colors (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.
The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. 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/K062541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062541: Calaview Colors (Etafilcon a) Soft (Hydrophilic) 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/K062541
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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