FreshLook One-Day Color Contact Lens
510(k) K050213
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050213 | Date28 Mar 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MVN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The FreshLook One-Day Color Contact Lens is a disposable soft contact lens designed to enhance or alter natural eye color. Classified as a cosmetic contact lens, it provides a range of youthful and vibrant hues while maintaining optical clarity for daily wear. These lenses are intended for individuals seeking temporary color changes without the need for permanent modifications.
Supplied as a single-use product, each lens is intended for one-day wear and disposal, ensuring hygiene and convenience. The lenses are non-prescription and do not correct vision but are available in various color options. They are regulated under FDA 510(k) clearance (K050213) and fall under the Ophthalmic specialty category. No sterilization or reusability is specified, and MRI safety is not addressed in the provided data.
Other devices from Ciba Vision Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the FreshLook One-Day Color Contact Lens used for?
The FreshLook One-Day Color Contact Lens is designed to enhance or alter natural eye color temporarily. It is classified as a cosmetic contact lens and is intended for individuals who want to change their eye color for aesthetic purposes without permanent modifications. These lenses do not correct vision and are meant for daily wear only.
How is the FreshLook One-Day Color Contact Lens supplied?
Each lens is supplied as a single-use product, meaning one lens is intended for one day of wear and should be discarded afterward. This ensures hygiene and convenience for users. The lenses come in various color options to suit different preferences.
Are the FreshLook One-Day Color Contact Lenses reusable or sterile?
The FreshLook One-Day Color Contact Lenses are intended for single-use only and are not designed for reuse. Since they are disposable, there is no need for sterilization procedures. Always follow the manufacturer’s instructions for proper use and disposal.
What sizes or models are available for the FreshLook One-Day Color Contact Lens?
The FreshLook One-Day Color Contact Lens is available in multiple registration numbers, indicating various models or color options. These models are categorized under the product code MVN and are intended for different aesthetic preferences. For specific sizing, refer to the manufacturer’s detailed product guide or consult an eye care professional.
How should the FreshLook One-Day Color Contact Lenses be stored?
Since these lenses are single-use and disposable, they should be stored in a clean, dry environment as per the manufacturer’s guidelines. If stored in a multi-pack or blister pack, ensure the packaging remains intact until use. Always check the expiration date and follow the instructions provided to maintain lens integrity.