510(k) · Cleared
Cleared(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Benz Research and Development Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 7, 1997 after a 115-day review. The FDA summary names its predicate without a number. 51 later devices descend from it.
- Decided
- Mar 7, 1997
- Review
- 115 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 11 citing it directly.
- This deviceK964528 (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft…Benz Research and Development Corp. · 1997
- Descendant · cites it directly · 34 of its ownK024045 Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for…Contamac, Ltd. · 2003
- Descendant · cites it directly · 33 of its ownK073621 Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon…Art Optical Contact Lens, Inc. · 2008
- Descendant · 2 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · 3 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 4 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd. · 2003 · cites it directly34descendants
- K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Art Optical Contact Lens, Inc. · 2008 · cites it directly33descendants
- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 2 generations on32descendants
- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 3 generations on12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)… | Benz Research and Development Corp. | 1997 | — |
| +1 | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear… | Contamac, Ltd. | 2003 | — |
| +1 | K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear… | Art Optical Contact Lens, Inc. | 2008 | — |
| +2 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +3 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +4 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | — | BENZ-G 55 (5X) (hioxifilcon A) Named without a submission number |
What descends from it? (51)
See all 5111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and… | 2003 | 34 |
| K073621 | Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue… | 2008 | 33 |
| K981252 | Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue… | 1998 | 6 |
| K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted… | 1998 | 3 |
| K982904 | Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens | 1998 | 3 |
| K120756 | LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a)… | 2013 | 2 |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49… | 2015 | 1 |
| K080686 | Westcon Horizon 49% (Hioxifilcon B) | 2008 | 0 |
| K060821 | Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses | 2006 | 0 |
| K983496 | Resolution 45 (Spherical) and Ultra Gel (Toric) (Hioxifilcon B) Soft Daily Wear Contact… | 1999 | 0 |
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?
- Of its descendants, K024045 (Contamac, Ltd., 2003) has gone furthest, with 34 descendants of its own.
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?
BENZ-G 3X Spherical (hioxifilcon B} soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes., The Spherical lenses are available from +20.00 to - 20.00 Diopters for versons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfere with…
Read the full statement (135 words)
BENZ-G 3X Spherical (hioxifilcon B} soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes., The Spherical lenses are available from +20.00 to - 20.00 Diopters for versons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfere with visual acuity.
BENZ-G 3X Toric (hioxifilcon B) soft (hydrcphilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.
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/K964528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964528
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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