# K962957: Rurasoft 2 Freshlook Colors; Durasoft 2 Freshlook Litetint

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Oct 1, 1996 after 63 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 its predicate without a number.
- (no number) DuraSoft 2 clear and tinted lathe cut soft (hydrophilic) contact lenses: named in the summary without a submission number

## Indications for use
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity. The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eye care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

Source page: https://510kreport.com/device/K962957
Methodology: https://510kreport.com/methodology