Biocurve Soft (Hioxifilcom A) Spherical and Toric Soft Contact Lens for Daily Wear
by American Contact Lens, Inc.
510(k) K011316
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011316 | Date13 Jun 2001 | 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- Withdrawn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
- Full name
- Biocurve Soft (Hioxifilcom a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear and Blue Visibility-Handling T
- 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, 19 Sep 2026
This device is a Lenses, Soft Contact, Daily Wear (per FDA nomenclature), designed for vision correction. It includes both spherical and toric configurations to address spherical refractive errors and astigmatism, respectively. The lenses are manufactured from Hioxifilcom A, a silicone hydrogel material, and are intended for daily wear with clear or blue visibility-handling options.
The Biocurve Soft lenses are supplied as single-use, non-sterile products for ocular application. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance (K011316) as substantially equivalent to a predicate device. Each lens is identified by specific FEI numbers and registration codes, ensuring traceability. Storage and handling follow standard contact lens protocols to maintain integrity before use.
Other devices from American Contact Lens, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these Biocurve Soft contact lenses designed for overnight wear, or are they strictly for daily use only?
The Biocurve Soft lenses are explicitly designed for daily wear only, as stated in the device description. They are not intended for extended or overnight use, which differentiates them from extended-wear or continuous-wear contact lenses.
What material are the Biocurve Soft lenses made from, and how does that affect their comfort or oxygen permeability?
The lenses are manufactured from Hioxifilcom A, a silicone hydrogel material. Silicone hydrogels are known for their higher oxygen permeability compared to traditional hydrogel materials, which can improve comfort and reduce dryness during wear, especially for longer daily use.
Are these lenses single-use, or can they be reused after proper cleaning and disinfection?
The Biocurve Soft lenses are supplied as single-use, non-sterile products for ocular application. They are not intended for reuse, even with cleaning or disinfection, as this would deviate from the manufacturer’s recommended use.
What visibility options are available for these lenses, and how might that affect patient selection?
The Biocurve Soft lenses come in clear and blue visibility-handling options. The blue visibility option may be preferred for patients who want a subtle tint for cosmetic purposes or easier lens handling, while the clear option is ideal for those who prefer a natural appearance.
How do I identify the correct lens from the list of FEI numbers provided, and are all models interchangeable?
Each lens is identified by a unique FEI number (e.g., 3015533540, 3012546757), which corresponds to specific spherical or toric prescriptions. These numbers ensure traceability and help select the correct lens for a patient’s refractive error. Not all models are interchangeable—the spherical lenses correct simple refractive errors, while the toric lenses address astigmatism, requiring separate ordering based on the patient’s prescription.