# K181796: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Aug 3, 2018 after 29 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 4.

## Indications for use
FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased 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 FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye. The eye care professional may prescribe the lens for frequent replacement with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K181796
Methodology: https://510kreport.com/methodology