510(k) · Cleared
ClearedUltravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact Lens (Clear & Yinted, Lathe-Cut From Lens)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opti-Centre Laboratories · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 2, 1998 as substantially equivalent to K964528 (Benz Research and Development Corp., 1997) after an 83-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 2, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964528 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964528 (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft…Benz Research and Development Corp. · 1997
- This deviceK974599 Ultravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily…Opti-Centre Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)… | Benz Research and Development Corp. | 1997 | — |
| 0 (this device) | K974599 | Ultravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact… | Opti-Centre Laboratories | 1998 | — |
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? (7)
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 |
|---|---|---|---|
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 3…ratories Opti-Center Inc. The established safety profile (pre-clinical toxicology and menufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X, 510(k) #K964528. Being similar with respect to indications for use, materials, physical construction and safety & effectivencss to the predicate… | 1997 |
| * | — | Bi-Soft Named without a submission number | |
| * | — | LifeStyle 4-Vue Named without a submission number | |
| * | — | LifeStyle Xtra Named without a submission number | |
| * | — | Horizon 55 Bicon Named without a submission number | |
| * | — | Ocu-Flex-53 Named without a submission number | |
| * | — | SimulVue 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.
What does this lineage say?
- Its one ancestor has no recall.
- 10 other devices also cite its predicate K964528.
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.
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 UltraVue/P, UlraVue/C (hioxifilcon B) Soft (Multifocal) Contact Lenses for daily wear arc indicated for the correction of visual acuity in aphakic and not aphakic persons with non-discased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit astigmatism of .75 diopters 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/K974599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974599: Ultravue/P, Ultralvue/C (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact Lens (Clear & Yinted, Lathe-Cut From Lens).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974599
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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