# K002099: S38 (Polymacon) Spherical, Aspherical, Toric and Multifocal Soft Contact Lens for Daily Wear (Clear and Tinted, Fully-

- Pathway: 510(k) (Traditional)
- Applicant: Bescon Co., Ltd.
- Decided: Jul 9, 2001 after 363 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 5, 2011 · Not classified · Z-0643-2012: This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.
- Dec 5, 2011 · Not classified · Z-0642-2012: This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.

Source page: https://510kreport.com/device/K002099
Methodology: https://510kreport.com/methodology