510(k) · Cleared
ClearedHydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visco Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Dec 7, 2020 as substantially equivalent to K040303 (Hydrogel Vision Corporation, 2005) and 1 other predicate after a 273-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Dec 7, 2020
- Review
- 273 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992692 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK992692 Extreme H20 (Hioxifilicon a) Soft Contact LensBenz Research and Development Corp. · 1999
- 1 generation backK040303 59% Extreme H2O (Hioxifilcon a) Soft Contact LensHydrogel Vision Corporation · 2005
- This deviceK200618 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact Lens | Benz Research and Development Corp. | 1999 | — |
| −1 | K040303 | 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens | Hydrogel Vision Corporation | 2005 | — |
| 0 (this device) | K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | Visco Vision, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K040303 | 59% Extreme H2O (Hioxifilcon a) Soft Contact LensSummary page 4…hioxifilcon A) Hydrogel Soft Contact Lens Trade Name: HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens 5. Predicate Device: K040303, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) K992692, 5… | 2005 |
| * | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact LensSummary page 4…Contact Lens 5. Predicate Device: K040303, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) K992692, 59% extreme H2O® soft contact lens 6. Device Description The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made… | 1999 |
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 21 years and passes through 3 companies; a new generation was cleared every 15.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K040303.
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. 2020, 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?
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
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/K200618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200618: HydroSens A (hioxifilcon A) Spherical Hydrogel Soft 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/K200618
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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