UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
FDA premarket approval P230012/S006 · decided 2025-04-30
Approval details
- PMA number
- P230012
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2025-04-08
- Decision date
- 2025-04-30
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lake Forest, CA
- Statement
- The manufacturing changes to the in-process seal strength integrity testing methodology from peel testing to burst and dye testing is approved.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |