UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
FDA premarket approval P230012 · decided 2024-08-26
Approval details
- 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
- Date received
- 2023-03-21
- Decision date
- 2024-08-26
- Days to decision
- 524 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lake Forest, CA
- Statement
- Approval for UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE SF6 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 SF6 Ophthalmic
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |