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FDAMarket Authorization
[PMA Approved] UNIPURE C3F8 Ophthalmic Gas in the — Alcon Research, LLC — P220030-S008
Feb 10, 2026
Decision Date: 2026-02-10Published: 2026-02-10Captured: 2026-02-24Alcon Research, LLCDevice: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery SystemProduct Code: LPO
FDA approved PMA P220030-S008 (decision: APPR). UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System by Alcon Research, LLC.
- •Trade name: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System
- •Applicant: Alcon Research, LLC
- •Decision: APPR
- •Supplement type: Real-Time Process
- •Product code: LPO
Decision:APPR
Device Class:3
Advisory Committee:OP
Supplement Type:Real-Time Process
Statement/Summary
increase of the dimension of the O-ring component used to create a seal between the plunger body and syringe barrel
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