# K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ocu-Ease Optical Products, Inc.
- Decided: Apr 26, 2002 after 53 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: 4 generations back to K961103 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens, Prosthetic Soft Lens Corp. (1999) Summary page 2.
- 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 2.

## Indications for use
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K020690
Methodology: https://510kreport.com/methodology