510(k) · Cleared
ClearedCVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unilens Corp., USA · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 30, 2014 after a 30-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Oct 30, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K082853 | FDA’s K082853 is Clinical Oxygen Dose Recorder (Codr), Model 300-CR Our reading of the summary gave K082853, FDA’s number for Clinical Oxygen Dose Recorder (Codr), Model 300-CR (Inspired Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for…”. Kept off the family tree. Summary page 6…The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device the same to the CVUE ADVANCED (hioxifilcon D), 510(k) K082853. The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses indications for use do not change Physical constru… | 2009 |
| * | — | LifeStyle MV2 Toric (polymacon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear Named without a submission number |
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.
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. 2014, 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?
The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity. The CVUE ADVANCED (hioxifilcon D) Toric and…
Read the full statement (138 words)
The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for
daily wear for the correction of refractive ametropia (myopia, hyperopia and
astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased
eyes. The lens may be worn by persons who require up to 3.00 Diopters of
add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with
visual acuity.
The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are
indicated for daily wear for the correction of refractive ametropia (myopia and
hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or notaphakic
persons with non-diseased eyes.
Eye care practitioners may prescribe the lens for frequent/planned replacement
wear, with cleaning, disinfection and scheduled replacement. When prescribed for
frequent/planned replacement wear, the lens may be disinfected using a chemical
disinfection system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142851: CVue ADVANCED (hioxifilcon D) 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/K142851
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026