# K994335: Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Mar 20, 2000 after 88 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 K965052 (1997). 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)
- K965052: D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses, Wesley Jessen Corp. (1997) Summary page 3.

## Indications for use
Spherical ProSoft™ Spherical (phemfilcon A) 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 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear. Toric ProSoft™ Toric (phemfilcon A) 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 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear. The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only. ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K994335
Methodology: https://510kreport.com/methodology