# K011577: Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone Toric Aspherical (Methafilcon a)S

- Pathway: 510(k) (Traditional)
- Applicant: Ocu-Ease Optical Products, Inc.
- Decided: Jun 19, 2001 after 28 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: 2 generations back to K954524 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992010: W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted), Westcon Contact Lens Co., Inc. (1999) Summary page 2.
- K980418: Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer, Benz Research and Development Corp. (1998) Summary page 4.
- K003861: Benz-MF (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens (Lathe-Cut), Benz Research and Development Corp. (2001) Summary page 4.

## Indications for use
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity. The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correct of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity. The lens may be disinfected with a chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K011577
Methodology: https://510kreport.com/methodology