# K960291: Tinted Ocu-Flex 53 (Occufilcon B) Soft Hydrophilic Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocu-Ease Optical Products, Inc.
- Decided: Mar 25, 1996 after 63 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)
- P820051: Ocu-Flex, Ocu-Ease Optical Products, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820051/S002 (Feb 20, 1986). Summary page 1.

## Indications for use
daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes.

Source page: https://510kreport.com/device/K960291
Methodology: https://510kreport.com/methodology