Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- B AND L 70 LIDOFILCON A CONTACT LENSE FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P880029 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses are soft contact lenses designed for extended wear, as defined by their generic name and device classification. They are intended for ophthalmic use to correct vision, specifically addressing astigmatism through their toric design.
These lenses are supplied as a reusable or extended-wear contact lens system, with authorization under FDA PMA P880029. They are manufactured by Bausch & Lomb, Inc. in Rochester, NY, and are classified as Class III medical devices under regulation number 886.5925, with product code LPM.
Frequently asked questions
What is the authorization status of the Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses?
The Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses are authorized under FDA PMA P880029, as indicated in the device data under the AUTHORIZATIONS field and confirmed by the pma_number specification.
What type of device are the Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses classified as?
They are classified as soft contact lenses for extended wear, based on the generic_name field in the specifications, which states 'Lenses, soft contact, extended wear', and the device_class=3 in the openfda field.
Who manufactures the Bausch & Lomb Medalist Toric (Lidofilcon A) Lenses and where are they located?
The lenses are manufactured by Bausch & Lomb, Inc., located at 1400 N. Goodman St., Rochester, NY 14609, as specified in the applicant, city, state, street_1, and zip fields.
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, Anmelden | Bausch Germany MC Site, Bausch & Lomb – Wikipedia, Startseite | Bausch + Lomb, Online Bestellen | Bausch + Lomb
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P880029 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P880029 24 fields · synced Sep 18, 2026