# K991550: Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (HYDROPHILIC0 Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: May 14, 1999 after 10 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 P830037 (1984). 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)
- P830037: Durasoft (R) 3 for Ext Wear, Alcon Laboratories, Inc. (1984) Summary page 3.

## Indications for use
FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity and presbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfere with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not aphakic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. FreshLook Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K991550
Methodology: https://510kreport.com/methodology