Specialty Tint Soft Contact Lens
510(k) K003079
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003079 | Date21 Nov 2000 | 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- Withdrawn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
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Soft Contact Lens, Daily Wear (per FDA nomenclature), designed to provide therapeutic, prosthetic, or cosmetic tinting for patients. It is intended for correction of visual conditions, enhancement of eye color, or protection against light sensitivity, including glare reduction and UV protection where applicable.
The lens is supplied as a single-use, sterile product for direct placement on the eye by a trained professional or patient. It is classified as Class II under FDA regulations and has received FDA 510K clearance as substantially equivalent to predicate devices. Multiple FEI numbers (e.g., 3015533540) correspond to registered product variants, each adhering to regulatory standards for ophthalmic use.
Questions
AI-generated answers, 18 Sep 2026
What are the primary purposes of the Specialty Tint Soft Contact Lens, and how does it differ from standard contact lenses?
The Specialty Tint Soft Contact Lens is designed for therapeutic, prosthetic, or cosmetic tinting to address specific patient needs. It can correct visual conditions, enhance eye color, or protect against light sensitivity, including glare reduction and UV protection where applicable. Unlike standard contact lenses, which primarily focus on vision correction, this lens incorporates tinting to serve additional aesthetic or protective functions while still being classified as a Daily Wear soft contact lens.
Are these lenses single-use or reusable, and how should they be handled to maintain sterility?
The Specialty Tint Soft Contact Lens is supplied as a single-use, sterile product. This means each lens is intended for one-time use only and should be discarded after removal from the eye. To maintain sterility, the lenses should be handled using aseptic techniques, such as wearing sterile gloves, and stored in their original packaging until immediate use. Avoid touching the lens surface to prevent contamination.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians or buyers?
The Specialty Tint Soft Contact Lens received FDA 510K clearance, which means it was determined to be substantially equivalent to a legally marketed predicate device. This clearance was granted under the Traditional 510(k) review pathway by the Ophthalmic Devices Advisory Committee (OP). Clinicians and buyers can rely on this clearance as evidence that the device meets FDA standards for safety and effectiveness as a Daily Wear soft contact lens with tinting capabilities.
How many variants of this lens are registered with the FDA, and what does this indicate about product availability?
The device has multiple registered variants, each associated with a unique FDA Establishment Inspection (FEI) number, totaling over 100 distinct product codes. This indicates a wide range of tinted options or sizes/models are available to cater to different patient needs, such as varying degrees of tint intensity, UV protection levels, or specific visual correction requirements. Buyers and clinicians can select from these variants based on their intended use.
What should be considered when storing these lenses before use, and are there any specific handling instructions?
The lenses should be stored in their original, sealed packaging to preserve sterility and prevent contamination. They should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures. Since they are single-use, it’s important to ensure the packaging remains intact until the moment of use. Avoid exposing the lenses to moisture or chemicals, as this could compromise their integrity or safety.