510(k) · Cleared
ClearedContaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contamac, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 26, 2003 as substantially equivalent to K980418 (Benz Research and Development Corp., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Feb 26, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980418 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK980418 Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and…Benz Research and Development Corp. · 1998
- This deviceK023989 Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily…Contamac, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980418 | Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft… | Benz Research and Development Corp. | 1998 | — |
| 0 (this device) | K023989 | Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear… | Contamac, Ltd. | 2003 | — |
| +1 | K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact… | Firestone Optics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K980418 | Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft…Summary page 2…e: “BENZ methafilcon A’ Manufactureddistributed by Benz Research and Development. 5 1O(k) number; K980418 Device Description: The CONTAFLEX 55 Spherical Soft Contact Lenses are fabricated from methafilcon A, which in the dry (unhydr… | 1998 |
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 |
|---|---|---|---|
| K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses… | 2014 | 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?
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 CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refiactive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may…
Read the full statement (105 words)
The CONTAFLEX 55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for
the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia
or hyperopia. The lens may be worn by persons who exhibit refiactive astigmatism of .75 diopters or
less where the astigmatism does not interfere with visual acuity.
The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequentlplanned replacement wear, with cleaning,
disinfection and scheduled replacement. When prescribed for fiequentlplanned replacement wear, the
lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023989: Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023989
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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