510(k) · Cleared
ClearedEYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Science Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 26, 2016 as substantially equivalent to K051430 (Hydrogel Vision Corporation, 2005) and 1 other predicate after a 127-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 26, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K992692 (1999). No later device cites it as a predicate yet.
- 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 backK153766 Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily…INTEROJO, Inc. · 2016
- This deviceK161124 EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily WearVision Science Co., Ltd. · 2016
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 | K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear… | INTEROJO, Inc. | 2016 | — |
| 0 (this device) | K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | Vision Science Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K051430 | Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)Summary page 6…“Extreme H2O 54% (hioxifilcon D) Soft Contact Lens” Hydrogel Vision Corporation 510(k) number; K051430 “Clalen 54 (Hioxifilcon D) Soft Contact Lens” Interojo Inc.… | 2005 |
| * | K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58…Summary page 6…number; K051430 “Clalen 54 (Hioxifilcon D) Soft Contact Lens” Interojo Inc. 510(k) number; K153766 “ISENS (polymacon)” ~ Reference Predicate Vision Science Co., Ltd.… | 2016 |
| † | K132714 | Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and… | 2014 |
| † | K051095 | 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | 2005 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K051430.
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. 2016, 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 EYEREVE (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of…
Read the full statement (231 words)
The EYEREVE (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The EYEREVE (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses 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 disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161124: EYEREVE (hioxifilcon D) 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/K161124
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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