510(k) · Cleared
ClearedFlexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Cel Contacts · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 12, 2007 as substantially equivalent to K043129 (Opti-Centre Laboratories, 2005) and 2 other predicates after a 39-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 12, 2007
- Review
- 39 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954524 (1996). 9 ancestors in all, the oldest P910029/
- Root · 4 generations backK954524 W-55 (Methafilon a) Contact LensWestcon Contact Lens Co., Inc. · 1996
- 3 generations backK992010 W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and…Westcon Contact Lens Co., Inc. · 1999
- 2 generations backK031774 Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc. · 2004
- 1 generation backK043540 Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc. · 2005
- This deviceK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
- Descendant · cites it directly · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954524 | W-55 (Methafilon a) Contact Lens | Westcon Contact Lens Co., Inc. | 1996 | — |
| −3 | K992010 | W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55… | Westcon Contact Lens Co., Inc. | 1999 | — |
| −2 | K031774 | Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses | Westcon Contact Lens Co., Inc. | 2004 | — |
| −1 | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses | Westcon Contact Lens Co., Inc. | 2005 | — |
| 0 (this device) | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… | X-Cel Contacts | 2007 | — |
| +1 | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +2 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens… | X-Cel Specialty Contacts, A Walman Optical Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K043129 | Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a)…Summary page 1…Flexlens Multifocal Soft Contact Lens Proclear Ultravue Multifocal (hioxifilcon A) (K(043129) Horizon 59 Oasis (hioxifilcon A)… | 2005 |
| * | K043540 | Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesSummary page 1…Horizon 59 Oasis (hioxifilcon A) Progressive (K(043540) Flexlens Multifocal Soft Contact Lens ESSTECII MULTI Aspheric (bioxifilcon B)… | 2005 |
| * | K982904 | Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact LensSummary page 1…Contact Lens ___ __ ___ ___ ___ ___ __ ___ ___ __ (1K 982904) X-Cel Contacts, Flexiens Multifocal Soft Contact Lens 510(k) - January 30, 2007… | 1998 |
| † | K983773 | Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens | 1998 |
| † | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100443 | Definitive, Flexlens - Silicone Hydrogel | 2010 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K100443 (X-Cel Contacts, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043129.
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. 2007, 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 Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070308: Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070308
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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