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 Sep 11, 2008 as substantially equivalent to K062854 (Benz Research and Development Corp., 2007) after a 23-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 11, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992692 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- 2 generations backK051430 Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and…Hydrogel Vision Corporation · 2005
- 1 generation backK062854 Benz-G 4X Hioxifilcon DBenz Research and Development Corp. · 2007
- This deviceK082393 Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact LensUnilens Corp., USA · 2008
- Descendant · cites it directly · 2 of its ownK100456 Cvue Advanced DefinitiveUnilens Corp., USA · 2010
- Descendant · 2 generations on · 0 of its ownK121652 Cvue Advanced Hydra VueUnilens Corp., USA · 2012
- Descendant · cites it directly · 0 of its ownK110452 Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue…Unilens Corp., USA · 2011
Most influential descendants
Showing 3 of 3 · See all- K100456Cvue Advanced DefinitiveUnilens Corp., USA · 2010 · cites it directly2descendants
- K121652Cvue Advanced Hydra VueUnilens Corp., USA · 2012 · 2 generations on0descendants
- K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| −2 | K051430 | Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) | Hydrogel Vision Corporation | 2005 | — |
| −1 | K062854 | Benz-G 4X Hioxifilcon D | Benz Research and Development Corp. | 2007 | — |
| 0 (this device) | K082393 | Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens | Unilens Corp., USA | 2008 | — |
| +1 | K100456 | Cvue Advanced Definitive | Unilens Corp., USA | 2010 | — |
| +2 | K121652 | Cvue Advanced Hydra Vue | Unilens Corp., USA | 2012 | — |
| +1 | K110452 | Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto… | Unilens Corp., USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K062854 | Benz-G 4X Hioxifilcon DSummary page 3…A. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 4X (hioxifilcon D), 510(k) K062854. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the… | 2007 |
| * | — | C-VUE® Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100456 (Unilens Corp., USA, 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062854.
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. 2008, 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 and Multifocal 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 non-diseased 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…
Read the full statement (139 words)
The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal 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 non-diseased 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 not-aphakic 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/K082393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082393: 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 5, 2026. https://510kreport.com/device/K082393
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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