PMA
P230012: UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
FDA PMA · Gases used within eye to place pressure on detached retina · Alcon Research, LLC
Key facts
| PMA number | P230012 |
|---|---|
| Trade name | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy |
| Generic name | Gases used within eye to place pressure on detached retina |
| Applicant | Alcon Research, LLC |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPO |
| Approval date | Aug 26, 2024 |
| Establishment registration | 3010208880 |
| FEI number | 3010208880 |
At a glance
- 10–99 Supplements
- Sep 30, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: