510(k) · Cleared
ClearedS-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech PS & SV (Polymacon) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nissel, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 16, 1999 as substantially equivalent to K942186 (Szabocsik and Assoc., 1994) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 16, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K942186 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942186 Esstech PS AsphericSzabocsik and Assoc. · 1994
- This deviceK990281 S-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech PS &…Nissel, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942186 | Esstech PS Aspheric | Szabocsik and Assoc. | 1994 | — |
| 0 (this device) | K990281 | S-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech PS & SV… | Nissel, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| Kept off the family tree | P920036 | S-38™ Soft (polymacon) Contact Lens Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…e Dye Blue #4). TOXICOLOGY: The lenses passed cytotoxicity, systemic toxicity and ocular irritation testing. MICROBIQLOGY All microbiological testing is contained in P920036. CLINICAL DATA Since there is no change other than the addition of a listed color additive, no new clinical data was generated.… | |
| * | K942186 | Esstech PS AsphericSummary page 1…oved PMA 920036 and the Essteche® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens covered in the 510(k)’'s K942186 and K942187, respectively. ¢Q ER K990281, FOI Summary Material Description Water Content Refractive Index L… | 1994 |
| * | K942187 | Esstech SV (Polymacon) Soft (Hydrophilic) Contact LensSummary page 1…036 and the Essteche® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens covered in the 510(k)’'s K942186 and K942187, respectively. ¢Q ER K990281, FOI Summary Material Description Water Content Refractive Index Light Transmi… | 1994 |
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.
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 S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear for the correction of wvisual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. 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 Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for…
Read the full statement (182 words)
The S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear for the correction of wvisual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. 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 Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic presbyopes. The lens may be worn by persons who may exhibit astigmatism of not more than 2.00 diopters that does not interfere with visual acuity.
The Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and/or marginally presbyopic requiring up to +1.00 D of add. The lens may be worn by persons who exhibit astigmatism of 1.50 diopters or less but may not be suitable for higher degrees of astigmatism.
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/K990281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990281: S-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech PS & SV (Polymacon) 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/K990281
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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