510(k) · Cleared
ClearedSpecialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Ultravision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 2, 2000 as substantially equivalent to K984090 (Specialty Ultravision, Inc., 1999) after a 103-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 2, 2000
- Review
- 103 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963488 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK963488 Specialty Progressive (Methafilcon a)Multifocal Soft…Specialty Ultravision, Inc. · 1996
- 1 generation backK984090 Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact…Specialty Ultravision, Inc. · 1999
- This deviceK993580 Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for…Specialty Ultravision, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963488 | Specialty Progressive (Methafilcon a)Multifocal Soft (Hydrophilic)Contact Lens… | Specialty Ultravision, Inc. | 1996 | — |
| −1 | K984090 | Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for… | Specialty Ultravision, Inc. | 1999 | — |
| 0 (this device) | K993580 | Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear | Specialty Ultravision, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K984090 | Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily…Summary page 1…vices: The Specialty 55 (methafilcon A) Soft Single Vision Contact Lens for Daily Wear was selected as the predicate device. This device, which was cleared under 510(k) K984090, is manufactured from the same polymer and the same lens design. Description of Devices: The Specialty 55 (methafilcon A) Soft… | 1999 |
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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a 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 Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
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/K993580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993580: Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993580
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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