Visco Soft Contact Lens
510(k) K141348
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141348 | Date22 Jun 2015 | 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- Withdrawn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, 1 Oct 2026
The Visco Soft Contact Lens is a Soft Contact Lens, Daily Wear (per FDA classification), designed for vision correction. These lenses are spherical and constructed from a silicone-hydrogel copolymer, combining hydrophilic and hydrophobic properties to enhance comfort and oxygen permeability for extended wear.
These lenses are intended for single-use or daily wear, supplied in sterile packaging for ophthalmic use. They are classified as Class II medical devices under FDA regulations (886.5925) and have received FDA 510(k) clearance as substantially equivalent to predicate devices. Multiple registration numbers and FEI codes correspond to various lens specifications, including different dioptric powers and base curves, ensuring compatibility with diverse prescriptive needs.
Other devices from Visco Vision, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Visco Soft Contact Lens designed for?
The Visco Soft Contact Lens is designed specifically for vision correction as a daily wear contact lens. It uses a silicone-hydrogel copolymer material, which balances hydrophilic and hydrophobic properties to enhance comfort and improve oxygen permeability. This design supports extended wear while maintaining clarity and eye health.
How is the Visco Soft Contact Lens supplied, and is it sterile?
The Visco Soft Contact Lens is supplied in sterile packaging, ensuring it is ready for immediate ophthalmic use without additional sterilization. This packaging is critical for maintaining sterility and safety before first use, particularly for single-use or daily disposable applications.
Are these lenses intended for single-use or reusable wear?
The Visco Soft Contact Lens is classified as suitable for single-use or daily wear, meaning it can be used once per day and discarded or reused according to clinical guidelines. The silicone-hydrogel material supports this flexibility while maintaining comfort and performance.
What dioptric powers and base curves are available for the Visco Soft Contact Lens?
The Visco Soft Contact Lens comes in multiple dioptric powers and base curves, as indicated by its various FEI codes and registration numbers. These variations ensure compatibility with a wide range of prescriptive needs, allowing clinicians to select the appropriate fit for each patient’s refractive error and corneal curvature.
How should the Visco Soft Contact Lens be stored?
The Visco Soft Contact Lens should be stored in its original, unopened sterile packaging until ready for use. Once opened, if the lens is intended for single-use, it should be used immediately and discarded. For daily wear lenses, follow manufacturer guidelines for proper storage in a clean, dry case with appropriate lens solution to maintain hygiene and prevent contamination.