# K023077: Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear (Lathe-Cut)

- Pathway: 510(k) (Traditional)
- Applicant: Ocu-Ease Optical Products, Inc.
- Decided: Dec 10, 2002 after 85 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 K950294 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950294: Flexlens 55 Soft (Hydrophilic) Contact Lens, Flexlens, Inc. (1996) Summary page 2.

## Indications for use
The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Spherical Soft Contact Lens are indicated for daily wear for the correction of hyperopia in pediatric aphakic persons. The lens may be disinfected with chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K023077
Methodology: https://510kreport.com/methodology