510(k) · Cleared
ClearedGelflex Delta Soft Contact Lens Material Methafilcon a 55% Water Content Clear or Blue Visitint, Gelflex Alpha Soft Cont
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gelflex · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 5, 2003 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 5, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 Gelflex Delta (methafilcon A) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes. The Gelflex Delta (methafilcon A) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Toric Soft Contact Lens is…
Read the full statement (372 words)
The Gelflex Delta (methafilcon A) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes. The Gelflex Delta (methafilcon A) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Delta (methafilcon A) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters.
The Gelflex Alpha (polymacon) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes. The Gelflex Alpha (polymacon) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (po1ymacon)Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Alpha (polymacon) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (polymacon) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters.
The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The Gelflex Delta (methafilcon A) Soft Contact Lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner. The Gelflex Alpha (polymacon) Soft Contact Lenses may be disinfected using heat, chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024003: Gelflex Delta Soft Contact Lens Material Methafilcon a 55% Water Content Clear or Blue Visitint, Gelflex Alpha Soft Cont.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024003
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026