# K993489: Crystal Custom Tinted Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Crystal Reflections, Int., Inc.
- Decided: Apr 14, 2000 after 182 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 K984098 (1999). 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)
- K984098: Adventure Tints, Color Enhanced Tinted Soft Contact Lens, Adventures IN Color Technology, Ltd. (1999) Summary page 5.

## Indications for use
The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye 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. The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye 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/K993489
Methodology: https://510kreport.com/methodology