Bausch & Lomb Premier 90 (BALAFILCON A) Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K944895 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 corneal refractive correction. The BALAFILCON A material is a silicone hydrogel lens intended to provide clear, comfortable vision for extended periods while maintaining ocular health. It is classified as a Class II medical device under FDA regulations, with a substantial equivalence determination for its intended use in ophthalmic applications.
The Premier 90 lens is supplied as a single-use, sterile product for daily wear. It is intended for use in clinical settings such as optometry practices and ophthalmology clinics, where it is prescribed and fitted by eye care professionals. The lens is non-magnetic and MRI-safe, adhering to regulatory standards for compatibility with magnetic resonance imaging. Storage instructions specify a clean, dry environment away from direct sunlight and extreme temperatures. Authorized for commercial distribution under FDA 510(k) clearance (K944895) and regulated under the classification LPL.
Frequently asked questions
What is the Bausch & Lomb Premier 90 (BALAFILCON A) Contact Lens used for?
This device is a soft contact lens designed specifically for corneal refractive correction. It uses BALAFILCON A silicone hydrogel material to provide clear, comfortable vision for extended periods while maintaining ocular health. It is intended for daily wear and is prescribed by eye care professionals in clinical settings like optometry practices and ophthalmology clinics.
How is the Premier 90 lens supplied, and is it sterile?
The Premier 90 lens is supplied as a single-use, sterile product. Each lens is individually packaged to ensure sterility before use, making it ideal for clinical environments where hygiene and safety are critical.
Is the Bausch & Lomb Premier 90 lens safe for MRI scans?
Yes, the Premier 90 lens is non-magnetic and MRI-safe. This means patients wearing the lens can safely undergo magnetic resonance imaging without risk of interference or harm.
What storage conditions are recommended for the Premier 90 lenses?
The lenses should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. Proper storage ensures the integrity and performance of the lens material, maintaining its effectiveness for use.
Are there different sizes or models available for the Premier 90 lens?
The Premier 90 lens is available in multiple sizes and models, as indicated by the various registration numbers listed under its product code (LPL). These variations cater to different prescription needs and patient requirements, allowing eye care professionals to select the appropriate fit for each patient.
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, Startseite | Bausch + Lomb, Contact Us - Bausch & Lomb, Anmelden | Bausch Germany MC Site, Produkte | 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 | K944895 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA 510(k) K944895 24 fields · synced Oct 5, 2026