510(k) · Cleared
ClearedDefinitive, Flexlens - Silicone Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Cel Contacts, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 28, 2010 as substantially equivalent to K100221 (Art Optical Contact Lens, Inc., 2010) and 3 other predicates after a 253-day review. Its family tree reaches back 6 generations to 1981. 1 later device descends from it.
- Decided
- Oct 28, 2010
- Review
- 253 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to P810005 (1981). 24 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 2 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 1 generation backK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- This deviceK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · cites it directly · 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 1 of 1 · See all- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −5 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −4 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −2 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −1 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| 0 (this device) | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K100221 | INTELLIWAVE3 Cleared while this submission was under review Summary page 2…"IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221 "Flexiens Multifocal (hioxifilcon B)" by X-Cel Contacts. 510(k… | 2010 |
| * | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearSummary page 2…510(k) number: K100221 "Flexiens Multifocal (hioxifilcon B)" by X-Cel Contacts. 510(k) number; K070308 "Bioifinitv (comnfilcon A)" by Coopervision, Inc. 510(k) numbe… | 2007 |
| * | K052560 | Biofinity (Comfilcon a) Soft Contact LensSummary page 2…510(k) number; K070308 "Bioifinitv (comnfilcon A)" by Coopervision, Inc. 510(k) number; K052560 "ActiFresh 400 (Iidofilcon A)" By Hydron Ltd. 510(k) number: K… | 2005 |
| * | K983637 | Actifresh 400 LensSummary page 2…510(k) number; K052560 "ActiFresh 400 (Iidofilcon A)" By Hydron Ltd. 510(k) number: K983637 Device Description: The Definitive, Flexlens Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | 2024 | 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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K242059 (X-Cel Specialty Contacts, A Walman Optical Company, 2024) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K100221.
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. 2010, 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 Definitive, Flexiens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of arretropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The Definitive, Flexiens, toric (efrofilcon A) Silicone Hydrogel Soft Contact…
Read the full statement (300 words)
The Definitive, Flexiens, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of arretropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Definitive, Flexiens, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Definitive, Flexiens, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Definitive, Flexiens, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Definitive, Flexiens, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of armetropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular comneal conditions such as keratoconus and post graft fitting
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100443: Definitive, Flexlens - Silicone Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100443
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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