Vassen Color
by Vassen Co., Ltd. 510(k)
Active
510(k) K141699
Overview
The Vassen Color is a Soft Contact Lens, Daily Wear, designed to enhance or alter natural eye color through cosmetic tinting. These lenses are classified under FDA product code LPL and fall under Class II medical devices, intended for temporary vision correction while providing aesthetic coloration.
These lenses are supplied as single-use, non-sterile items, intended for daily wear only. They are regulated under FDA 510(k) clearance (K141699) and comply with 21 CFR 886.5925. Multiple FEI numbers (e.g., 3015533540, 3012546757) correspond to various color and prescription variants. Storage and handling follow standard ophthalmic contact lens guidelines, with no MRI safety restrictions noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141699 | Date7 Oct 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Questions
Are the Vassen Color lenses designed for continuous wear, or are they only meant for daily use?
The Vassen Color lenses are explicitly labeled for daily wear only, not continuous wear. This classification aligns with standard soft contact lens guidelines, ensuring safe and temporary use without extended exposure risks.
How do I know which FEI number corresponds to the specific color or prescription variant I need?
The Vassen Color lenses come in multiple variants, each assigned a unique FEI number (e.g., 3015533540, 3012546757). Since these numbers correlate directly to color and prescription combinations, you should consult the manufacturer’s catalog or a certified optometrist to match your requirements with the correct FEI. The full list of FEIs is available in the FDA’s OpenFDA database.
Do these lenses require sterilization before use, or are they pre-sterilized?
The Vassen Color lenses are non-sterile and supplied as single-use items. They follow standard ophthalmic contact lens handling protocols, meaning no additional sterilization is required before use. Always adhere to proper hygiene practices as outlined in contact lens care guidelines.
Are there any restrictions on using these lenses in medical imaging, like MRI scans?
The Vassen Color lenses do not have any MRI safety restrictions noted in their documentation. However, since they are cosmetic and not medical imaging-compatible devices, standard MRI precautions (e.g., removing all non-essential metal objects) should still be followed to avoid interference or safety hazards.