510(k) · Cleared
ClearedSofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gelflex Laboratories · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 6, 2018 as substantially equivalent to K051095 (Optical Connection, Inc., 2005) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Sep 6, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to P820021 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backP820021 Softcon (Vifilcon a) Soft Contact Ext Wear LensAlcon Laboratories, Inc. · 1983
- This deviceK181558 Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear…Gelflex Laboratories · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear Lens | Alcon Laboratories, Inc. | 1983 | — |
| 0 (this device) | K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors… | Gelflex Laboratories | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K051095 | 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearSummary page 5…ing predicate device(s): ƒ “55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear” Optical Connection, Inc. 510(k) number; K051095 Primary Predicate ƒ “Focus Softcolors (vifilcon A) Soft (Hydrophilic) Contact Lenses” Alcon Labora… | 2005 |
| * | P820021 | Softcon (Vifilcon a) Soft Contact Ext Wear LensSummary page 5…1095 Primary Predicate ƒ “Focus Softcolors (vifilcon A) Soft (Hydrophilic) Contact Lenses” Alcon Laboratories, Inc. PMA number; P820021 (S025) Reference Predicate x “Frequency Colors (methafilcon A)” By Coopervision, Inc. 5… | 1983 |
| * | K001090 | Methafilcon aSummary page 5…PMA number; P820021 (S025) Reference Predicate x “Frequency Colors (methafilcon A)” By Coopervision, Inc. 510(k) number; K001090 Reference Predicate IV. DEVICE DESCRIPTION Sofclear Enhance (methafilcon A) Daily Wear Contact Lens The Sof… | 2000 |
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?
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K051095.
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. 2018, 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 Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the…
Read the full statement (170 words)
The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
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/K181558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181558: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181558
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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