# K991995: Softchrome Tints, Transparent Tinted Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Softchrome, Inc.
- Decided: Aug 27, 1999 after 74 days
- Product code: MZD (System, In-Office Tinting, Contact Lenses)
- 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) Adventure Tints Color Enhanced Soft Contact Lens: named in the summary without a submission number

## Indications for use
The SOFTCHROME TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect 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 may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K991995
Methodology: https://510kreport.com/methodology