# K990815: Colorsoft, Color Enhanced Tinted Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Colorsoft Laboratories Corp.
- Decided: Jun 3, 1999 after 84 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 COLORS tinted soft contact lens: named in the summary without a submission number

## Indications for use
The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color. Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer’s recommendation.

Source page: https://510kreport.com/device/K990815
Methodology: https://510kreport.com/methodology