Novakone Spherical and Toric Lenses
510(k) K102557
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102557 | Date26 Apr 2011 | StatusActive |
Recalls
-
- Terminated Z-0982-2018
- Terminated Z-0981-2018
Contact lenses lack sterility assurance.
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- Withdrawn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 Novakone Spherical and Toric Lenses are soft contact lenses designed for daily wear, classified under the FDA’s device type for Soft Contact Lenses. These lenses are engineered to correct vision in patients with irregular corneal shapes, such as keratoconus or pellucid marginal degeneration, by providing precise optical alignment and addressing irregular astigmatism through variable lens center thickness and optimized base curves.
Supplied as single-use lenses, these devices are intended for ophthalmic use and have received FDA 510(k) clearance under the Traditional pathway. They are not MRI-safe or reusable and must be handled in sterile conditions. The product codes (e.g., 3015533540, 3012546757) identify specific lens variants, which vary in parameters like base curve and toric power. Storage and handling follow standard contact lens protocols to maintain sterility and performance.
Other devices from Alden Optical Labs., Inc.
Questions
AI-generated answers, 1 Oct 2026
What conditions are the Novakone Spherical and Toric Lenses intended to treat?
These lenses are specifically engineered to correct vision in patients with irregular corneal shapes, such as keratoconus or pellucid marginal degeneration. The design addresses irregular astigmatism through variable lens center thickness and optimized base curves, ensuring precise optical alignment for improved visual clarity.
Are the Novakone Spherical and Toric Lenses reusable or single-use?
The Novakone Spherical and Toric Lenses are supplied as single-use lenses. This design ensures sterility and reduces the risk of contamination or infection, which is critical for ocular health and compliance with standard contact lens protocols.
How should these lenses be stored and handled?
Storage and handling follow standard contact lens protocols to maintain sterility and performance. Since they are single-use, each lens should be opened only once and used immediately after removal from its sterile packaging. Avoid exposing the lenses to moisture, dust, or direct sunlight before use.
Are there different models or variants of the Novakone Spherical and Toric Lenses?
Yes, the Novakone Spherical and Toric Lenses come in multiple variants, each identified by specific product codes (e.g., 3015533540, 3012546757). These variants vary in parameters like base curve and toric power, allowing clinicians to select the most appropriate lens for a patient’s unique corneal shape and refractive needs.
Can these lenses be used in an MRI machine?
No, the Novakone Spherical and Toric Lenses are not MRI-safe. Patients wearing these lenses should remove them before undergoing an MRI scan to avoid potential risks associated with magnetic fields, which could damage the lenses or cause harm to the patient.