UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

FDA premarket approval P230012 · Gases used within eye to place pressure on detached retina

PMA numberP230012

Approval

Applicant
Alcon Research, LLC
Received
March 21, 2023
Decision date
August 26, 2024 (APPR)
Supplements
10, latest May 28, 2026
Product code
LPO – Gases Used Within Eye To Place Pressure On Detached Retina

Official FDA PMA record

Approval order statement

Approval for UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, laser photocoagulation, and air/gas exchange.The UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, and laser photocoagulation.