# K041138: Leo Colors, Leo Aspheric Colors, Leo Toric Colors

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Jul 23, 2004 after 84 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: 3 generations back to K951893 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971164: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens, Aspect Vision Care, Ltd. (1997) Summary page 3.
- K001090: Methafilcon a, CooperVision, Inc. (2000) Summary page 3.
- K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear, Aspect Vision Care, Ltd. (1997) Summary page 4.

## Indications for use
Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia. When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner. When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

Source page: https://510kreport.com/device/K041138
Methodology: https://510kreport.com/methodology