510(k) · Cleared
ClearedFlexlens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexlens, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 1, 1996 after a 134-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Oct 1, 1996
- Review
- 134 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK961943 FlexlensFlexlens, Inc. · 1996
- Descendant · cites it directly · 9 of its ownK080512 Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon…Metro Optics of Austin, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · 4 generations on · 4 of its ownK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
- Descendant · 5 generations on · 3 of its ownK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080512Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue…Metro Optics of Austin, Inc. · 2008 · cites it directly9descendants
- K100244Metro SoftMetro Optics of Austin, Inc. · 2010 · 2 generations on8descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 3 generations on5descendants
- K161288LenSX Laser SystemAlcon Laboratories, Inc. · 2016 · 4 generations on4descendants
- K163551LenSx Laser SystemAlcon Laboratories, Inc. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961943 | Flexlens | Flexlens, Inc. | 1996 | — |
| +1 | K080512 | Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear… | Metro Optics of Austin, Inc. | 2008 | — |
| +2 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
| +3 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +4 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
| +5 | K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | — | FLEXTENS Custom Sphere Named without a submission number |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K080512 (Metro Optics of Austin, Inc., 2008) has gone furthest, with 9 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?
The FLEXTENS (hefilcon A) HARRISON Post Refractive Surgery Contact Lens is indicated for Daily Wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
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/K961943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961943: Flexlens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961943
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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