510(k) · Cleared
ClearedFlexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B), (Acofilcon a), (Acofilcon B) Soft Contac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Cel Contacts, A Walman Co. · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 30, 2003 as substantially equivalent to K950294 (Flexlens, Inc., 1996) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 30, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K950294 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK950294 Flexlens 55 Soft (Hydrophilic) Contact LensFlexlens, Inc. · 1996
- This deviceK030593 Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a)…X-Cel Contacts, A Walman Co. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950294 | Flexlens 55 Soft (Hydrophilic) Contact Lens | Flexlens, Inc. | 1996 | — |
| 0 (this device) | K030593 | Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon… | X-Cel Contacts, A Walman Co. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K950294 | Flexlens 55 Soft (Hydrophilic) Contact LensSummary page 2…predicate devices. 0 Flexlens (methafilcon A) Harrison Post Refiactive Surgery Soft Contact Lens for Daily Wear manufactured by X-cel / Flexlens Products (K950294) 0 Flexlens (hefilcon A) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear manufactured by X-cel /… | 1996 |
| * | K961943 | FlexlensSummary page 2…ens Products (K950294) 0 Flexlens (hefilcon A) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear manufactured by X-cel / Flexlens Products (K96 1943) 0 Flexlens 55 Soft (Hydrophilic) manufactured by X-cel Contacts / Flexlens Products 6 9 5 0 2 9 5 ) Device Description:… | 1996 |
| Kept off the family tree | K950295 | FDA’s K950295 is Wound Closure/Laceration Tray Our OCR of the scanned summary read K950295, FDA’s number for Wound Closure/Laceration Tray (Customed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Flexlens 55 Soft (Hydrophilic)”. Kept off the family tree. | 1995 |
| † | K983773 | Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens | 1998 |
| † | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses… | 1997 |
| † | K023349 | Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and… | 2002 |
| † | K024045 | Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and… | 2003 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K950294.
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 Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty. The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A)…
Read the full statement (113 words)
The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.
The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.
The lens may be disinfected with a chemical (not heat) 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/K030593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030593: Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B), (Acofilcon a), (Acofilcon B) Soft Contac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030593
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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