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  6. UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPEXY Gas Delivery System – P220030
  1. Recently-Approved Devices

UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPEXY Gas Delivery System – P220030

UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System

PMA Applicant: Alcon Research, LLC

Address: 20511 Lake Forest Drive, Lake Forest, CA 92630, USA

Approval Date: July 2, 2024

Approval Letter: Approval order

What is it?

UNIPURE C3F8 Ophthalmic Gas is a gas that can be injected into the eye for the treatment of uncomplicated retinal detachment. The UNIPURE C3F8 Ophthalmic Gas is delivered through one of two delivery systems: the UNIFEYE Gas Delivery System or the UNIPEXY Gas Delivery System.

The UNIFEYE Gas Delivery System injects filtered UNIPURE C3F8 Ophthalmic Gas mixed with filtered air into the eye. The UNIPEXY Gas Delivery System injects undiluted, filtered UNIPURE C3F8 Ophthalmic Gas into the eye.

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