510(k) · Cleared
ClearedMethafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to BE Marketed YR. 2000), Frequency 55 Asp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · MVN Lens, Contact, (Disposable)
Cleared on Nov 24, 1999 as substantially equivalent to K973063 (Aspect Vision Care, Ltd., 1997) and 1 other predicate after a 57-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Nov 24, 1999
- Review
- 57 days
- Class
- Class II
- Product code
- MVN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951893 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 3 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 2 generations backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- 1 generation backK982997 Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily…Aspect Vision Care, Ltd. · 1999
- This deviceK993252 Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55…CooperVision, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK181230 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181230Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55…Largan Medical Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −3 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −2 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| −1 | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear… | Aspect Vision Care, Ltd. | 1999 | — |
| 0 (this device) | K993252 | Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV… | CooperVision, Inc. | 1999 | — |
| +1 | K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MVN? 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 MVN device
- #1 K261812 HOYA Illumina (sorafilcon A) Daily Disposable…score 14.0 · 9 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K871164 | FDA’s K871164 is Gluma (TM) Bonding System Our OCR of the scanned summary read K871164, FDA’s number for Gluma (TM) Bonding System (Columbus Dental Mfg. Co.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 2…matism) in not-aphakic persons with non-diseased eyes. 8. Technological Characteristics: Design, material, and chemical composition are unchanged from those cleared in K871164, K973063, and K982997. 9. Summary of Non-Clinical/Clinical Tests: No Non-Clinical or Clinical tests were performed. The lenses… | 1987 |
| * | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearSummary page 2…n not-aphakic persons with non-diseased eyes. 8. Technological Characteristics: Design, material, and chemical composition are unchanged from those cleared in K871164, K973063, and K982997. 9. Summary of Non-Clinical/Clinical Tests: No Non-Clinical or Clinical tests were performed. The lenses are the s… | 1997 |
| * | K982997 | Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and…Summary page 2…persons with non-diseased eyes. 8. Technological Characteristics: Design, material, and chemical composition are unchanged from those cleared in K871164, K973063, and K982997. 9. Summary of Non-Clinical/Clinical Tests: No Non-Clinical or Clinical tests were performed. The lenses are the same as those… | 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 |
|---|---|---|---|
| K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55… | 2018 | 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 4 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K181230 (Largan Medical Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K973063.
How does its category compare?
All MVN devicesMVN Lens, Contact, (Disposable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · MVN
Too few MVN 510(k)s in any year since 2007 to give a median.
Recalls per year · MVN
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVN
22in 2025
MAUDE reports naming product code MVN, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 1 | — | 2 | 35 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 2 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 23 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 2 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, CooperFlex and Onevue are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with usual acuity. Frequency 55 lenses with UV absorbing monomer helps protect against transmission of harmful UV…
Read the full statement (204 words)
Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, CooperFlex and Onevue are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with usual acuity.
Frequency 55 lenses with UV absorbing monomer helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Encore Toric lenses are indicated for daily for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Frequency 55, Frequency 55 Aspheric, Frequency 55 UV, Encore, Encore Toric, CooperFlex and Onevue lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitoner.
Disposable Wear
When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at 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/K993252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993252: Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to BE Marketed YR. 2000), Frequency 55 Asp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993252
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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