Bausch + Lomb Bioture Oneday For Presbyopia (nesofilcon A) Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132715 FDA 510(k)
- FDA Product Code
- LPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Soft Contact Lens, Daily Wear, designed for presbyopia correction. It is classified as a Class II medical device under FDA regulations and is intended for single-use, daily disposable application. The lens incorporates a multifocal design to provide clear vision at multiple distances, including near, intermediate, and distance, while maintaining comfort and hydration for the eye.
The Biotrue OneDay for Presbyopia lens is supplied as a sterile, single-use product, requiring no cleaning or maintenance beyond removal after each wear. It is intended for use in ophthalmic settings by trained eye care professionals. The lens is packaged individually and must be stored in a clean, dry environment, protected from direct sunlight and extreme temperatures. Authorized for use in the United States under an FDA 510(k) clearance (K132715), it adheres to regulatory standards for soft contact lenses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bausch + Lomb Official Home Page, For Professionals: Biotrue® ONEday for Presbyopia, For Eye Care Professionals: Bausch + Lomb Biotrue® ONEday, Bausch & Lomb – Wikipedia, Biotrue® ONEday | Daily Contact Lenses by Bausch + Lomb
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132715 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- FDA Applicant
- Bausch & Lomb, Incorporated
Sources (1)
- FDA 510(k) K132715 24 fields · synced Oct 6, 2026