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Iolab Surefit Anterior Chamber Intraocular Lenses

FDA PMA

Class III (US FDA PMA)

PMA P870013

by Bausch and Lomb

Identity

Trade Name
IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P870013 FDA PMA
FDA Product Code
HQL FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.3600 FDA PMA
Regulation Number
886.3600 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APWD FDA PMA

The Iolab Surefit anterior chamber intraocular lenses are ophthalmic devices designed for surgical use within the eye. These lenses are manufactured by Bausch and Lomb and are categorized as class 3 medical devices under FDA regulation number 886.3600.

This device is authorized for use under FDA PMA number P870013. It is available in specific configurations including models 85JS, 85JM, and 85JL to accommodate different clinical requirements.

Frequently asked questions

What is the purpose of the Iolab Surefit intraocular lens?

The Iolab Surefit is an anterior chamber intraocular lens designed for ophthalmic surgical procedures as indicated by its classification and regulatory authorization.

Who is the manufacturer of these lenses?

These intraocular lenses are manufactured by Bausch and Lomb, based in Rochester, New York.

Are there different sizes available for this device?

Yes, the product line includes specific models identified as 85JS, 85JM, and 85JL to provide options for surgical application.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch and Lomb
FDA Applicant
Bausch & Lomb

Sources (1)

  • FDA PMA P870013 24 fields · synced Oct 6, 2026