# P220030: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

- Pathway: PMA
- Applicant: Alcon Research, LLC
- Decided: Jul 2, 2024 after 564 days
- Product code: LPO (Gases Used Within Eye To Place Pressure On Detached Retina)
- Device class: 3
- Regulation: 21 CFR 886.4270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P220030
Methodology: https://510kreport.com/methodology