510(k) · Cleared
ClearedEsstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Les Laboratoires Blanchard · LPL Lenses, Soft Contact, Daily Wear
Cleared on Sep 1, 1998 as substantially equivalent to K964528 (Benz Research and Development Corp., 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Sep 1, 1998
- Review
- 14 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P910029/
- Root · 1 generation backP910029/
S001 Hydron (R) (Polymacon) Hydrophilic Contact LensesLes Laboratories Blonchard · 1993 - This deviceK982904 Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft…Les Laboratoires Blanchard · 1998
- Descendant · cites it directly · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
- Descendant · 2 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024
Most influential descendants
Showing 3 of 3 · See all- K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007 · cites it directly2descendants
- K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010 · 2 generations on1descendant
- K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P910029/ | Hydron (R) (Polymacon) Hydrophilic Contact Lenses | Les Laboratories Blonchard | 1993 | — |
| 0 (this device) | K982904 | Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact… | Les Laboratoires Blanchard | 1998 | — |
| +1 | K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… | X-Cel Contacts | 2007 | — |
| +2 | K100443 | Definitive, Flexlens - Silicone Hydrogel | X-Cel Contacts, Inc. | 2010 | — |
| +3 | K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens… | X-Cel Specialty Contacts, A Walman Optical Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 1…Contact Lens Class II (Performance Standards) 21 CFR 886.5925, 86LPL Lenses, Soft Contact, Daily Wear This lens is made in hioxifilcon B, the same material as cited in K964528 (Marx 10, 1997) and is identical in design to the ESSTECH® PS Aspheric (polymacon) Soft (hydrophilic) Contact Lens, P910029/S1 (J… | 1997 |
| * | P910029/ | Hydron (R) (Polymacon) Hydrophilic Contact Lenses A supplement to the PMA, as the summary prints it. | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear | 2007 | 2 |
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?
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 ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased eyes. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.
The lens may be disinfected using either heat (thermal) or chemical (not heat) 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/K982904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982904: Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982904
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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