# K992466: Ocu-Flex-38 Keratoconus (Polymacon) Soft Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Ocu-Ease Optical Products, Inc.
- Decided: Oct 4, 1999 after 73 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.
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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P17976: Harrison Keratoconus Lens. Number could not be read Summary page 2.

## Indications for use
The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected using a chemical or heat disinfecting systems.

Source page: https://510kreport.com/device/K992466
Methodology: https://510kreport.com/methodology