510(k) · Cleared
ClearedPrecision UV (Vasurfilcon a)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pilkington Barnes-Hind, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 1, 1996 as substantially equivalent to K946012 (Pilkington Barnes-Hind, Ltd., 1995) after a 180-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Oct 1, 1996
- Review
- 180 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946012 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982988Precision UV (Vasurfilcon a)Wesley Jessen Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946012 | Precision UV (TM) (Vasurficon a) | Pilkington Barnes-Hind, Ltd. | 1995 | — |
| 0 (this device) | K961299 | Precision UV (Vasurfilcon a) | Pilkington Barnes-Hind, Ltd. | 1996 | — |
| +1 | K982988 | Precision UV (Vasurfilcon a) | Wesley Jessen Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K946012 | Precision UV (TM) (Vasurficon a)Summary page 1…blue-green locator tint (D&C Green No. 6, C.I. No. 61565) in an in-monomer tinting process. On January 24, 1995, PBH received clearance in Premarket 510(k) Notification K946012 to tint molded Precision UV™ (vasurfilcon A) with a light blue locator tint (Vat Blue No. 6, C.I. No. 69825) using a post-lens ma… | 1995 |
| † | P890020 | Fluorocon TM-60 | 1989 |
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 |
|---|---|---|---|
| K982988 | Precision UV (Vasurfilcon a) | 1999 | 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?
- Its one ancestor has no recall.
- Of its descendants, K982988 (Wesley Jessen Corp., 1999) has gone furthest, with 0 descendants of its own.
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?
Precision UV™ (vasurfilcon A) Hydrophilic contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters (D) or less of corneal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear as recommended by the eye care practitioner.
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/K961299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961299: Precision UV (Vasurfilcon a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961299
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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