510(k) · Cleared
ClearedCvue Advanced Hydra Vue
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 5, 2012 as substantially equivalent to K100221 (Art Optical Contact Lens, Inc., 2010) and 2 other predicates after a 122-day review. Its family tree reaches back 7 generations to 1981.
- Decided
- Oct 5, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to P810005 (1981). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 2 generations backK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- 1 generation backK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
- This deviceK121652 Cvue Advanced Hydra VueUnilens Corp., USA · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −6 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −5 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −4 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −3 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −2 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| −1 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
| 0 (this device) | K121652 | Cvue Advanced Hydra Vue | Unilens Corp., USA | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K100221 | INTELLIWAVE3Summary page 1…lowing predicate devices: lntelliWave3, Silicone Hydrogel Daily Wea r Soft Contact Lens (efrofilcon A) By Art Optical Contact Lens, Inc. 51 0(k) number K1 00221 Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) By Metro Optics of Austin Inc. 51 0(k)… | 2010 |
| * | K100244 | Metro SoftSummary page 1…c. 51 0(k) number K1 00221 Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) By Metro Optics of Austin Inc. 51 0(k) number K1 00244 CVue Advanced Definitive Daily Wear Soft Contact Lens (efrofilcon A) By Unilens Corp., USA 51 0(k) number K1 00… | 2010 |
| * | K100456 | Cvue Advanced DefinitiveSummary page 1…of Austin Inc. 51 0(k) number K1 00244 CVue Advanced Definitive Daily Wear Soft Contact Lens (efrofilcon A) By Unilens Corp., USA 51 0(k) number K1 00456 Device Description: The CVue Advanced HydraVUE (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel contact lenses for daily wear… | 2010 |
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 31 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 24 ancestors have a recall of any class.
- 10 other devices also cite its predicate K100221.
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. 2012, 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 HydraVUE Irregular Cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eye care practitioners may…
Read the full statement (106 words)
The CVue Advanced HydraVUE Irregular Cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
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 (not heat) lens care system or hydrogen peroxide disinfection system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121652: Cvue Advanced Hydra Vue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121652
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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