PMA P230012S008

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S008
Product code: LPO
Decision date: 2026-02-10
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: increase of the dimension of the O-ring component used to create a seal between the plunger body and syringe barrel

Current openFDA PMA Record#

Device: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
Applicant: Alcon Research, LLC
PMA number: P230012
Supplement: S008
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-02-10
Decision code: APPR
Date received: 2025-08-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: increase of the dimension of the O-ring component used to create a seal between the plunger body and syringe barrel