UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
FDA premarket approval P220030 · decided 2024-07-02
Approval details
- PMA number
- P220030
- Trade name
- UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Alcon Research, LLC
- Date received
- 2022-12-16
- Decision date
- 2024-07-02
- Days to decision
- 564 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lake Forest, CA
- Statement
- Approval for UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE C3F8 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 C3F8 Ophtha
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |