510(k) · Cleared
ClearedActitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydron, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 18, 1999 as substantially equivalent to K963764 (Specialty Ultravision, Inc., 1997) after a 162-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 18, 1999
- Review
- 162 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963764 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963764 Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSpecialty Ultravision, Inc. · 1997
- This deviceK983160 Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for…Hydron, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963764 | Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear | Specialty Ultravision, Inc. | 1997 | — |
| 0 (this device) | K983160 | Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily Wear | Hydron, Ltd. | 1999 | — |
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 |
|---|---|---|---|
| * | K963764 | Specialty T Toric (Ocufilcon a) Contact Lens for Daily WearSummary page 4…y Wear is equivalent to Specialty UltraVision Specialty T (ocufiicon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear approved by the FDA under 510(k) application K963764, Jan. 1997. ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is substantially equivalent to the indi… | 1997 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K963764.
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 Hydron ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and non-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.
Eyecare practitioners may prescribe the lens for planned frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
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/K983160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983160: Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983160
Report an extraction error
Are you the manufacturer?
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