# K001089: Polymacon

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: May 19, 2000 after 45 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K151847: SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens (2016), 0 descendants of its own
- K011893: Cosmetica (Polymacon) Soft (Hydrophilic) Contact Lenses (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K001089
Methodology: https://510kreport.com/methodology