# K993935: Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Dec 21, 1999 after 32 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)
- None. The FDA summary names no predicate by number.

## Indications for use
Spherical DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. OptiFit Toric DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the comrection of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear. Prosthetic DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) 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 comeal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lenses are indicated for Daily Wear in not-aphakic and/or aphakic persons. The eye care practitioner may prescribe the lens for daily use with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eye.

Source page: https://510kreport.com/device/K993935
Methodology: https://510kreport.com/methodology