Discon (Etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
510(k) K051129
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051129 | Date12 Aug 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- Withdrawn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
- LPL
- FDA applicant
- Innova Vision, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a Soft Contact Lens, Daily Wear (FDA nomenclature), designed for correcting refractive errors in non-aphakic eyes with myopia, hyperopia, or refractive astigmatism up to 2.00 diopters. Constructed from etafilcon A, a hydrophilic material, it provides optical correction for patients with non-diseased eyes requiring daily vision adjustment.
Prescribed by eye care practitioners, this lens is intended for daily wear and is supplied in sterile, single-use packaging. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance as substantially equivalent. Multiple product codes (e.g., 3015533540, 3012546757) identify specific variants, all adhering to regulatory standards for ophthalmic devices. Storage and handling follow standard contact lens protocols to maintain sterility and performance.
Other devices from Innova Vision Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of vision issues can the DISCON (etafilcon A) contact lens correct, and who is it intended for?
The DISCON (etafilcon A) soft contact lens is designed for correcting refractive errors in non-aphakic eyes, meaning eyes that are not without a natural lens due to surgery or disease. It addresses myopia (nearsightedness), hyperopia (farsightedness), and refractive astigmatism up to 2.00 diopters. It is intended for patients with healthy eyes who require daily vision correction and is prescribed by eye care practitioners.
Is the DISCON contact lens single-use or reusable, and how is it packaged to maintain sterility?
The DISCON (etafilcon A) contact lens is supplied in sterile, single-use packaging. This design ensures that each lens remains uncontaminated and ready for immediate use, adhering to standard contact lens protocols for sterility and performance.
How many different product codes or variants of the DISCON contact lens exist, and what does this indicate about its availability?
The DISCON (etafilcon A) contact lens includes multiple product codes (over 70 listed), each corresponding to specific variants. These variants likely represent different lens powers, diameters, or other clinical specifications to accommodate a wide range of prescriptions. This extensive range indicates broad availability for diverse patient needs.
What material is the DISCON contact lens made from, and how does this affect its use?
The DISCON contact lens is constructed from etafilcon A, a hydrophilic (water-absorbing) material. This material is designed to provide comfort and clarity for daily wear, allowing the lens to retain moisture and conform to the eye’s surface effectively. It is intended for continuous daily use as prescribed by eye care professionals.
What regulatory pathway was followed for the DISCON contact lens, and what does this mean for its use in clinical settings?
The DISCON (etafilcon A) contact lens received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This pathway ensures that the lens meets FDA standards for safety and effectiveness as a Class II medical device, allowing it to be legally prescribed and dispensed by eye care practitioners in clinical settings.