# K990281: S-38 (Polymacon) Soft (Hydrophilic) Contact Lens, the Esstech PS & SV (Polymacon) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Nissel, Ltd.
- Decided: Apr 16, 1999 after 78 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942186 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942186: Esstech PS Aspheric, Szabocsik and Assoc. (1994) Summary page 1.
- K942187: Esstech SV (Polymacon) Soft (Hydrophilic) Contact Lens, Szabocsik and Assoc. (1994) Summary page 1.

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K990281
Methodology: https://510kreport.com/methodology