UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
FDA premarket approval P230012/S001 · decided 2024-10-22
Approval details
- PMA number
- P230012
- Supplement
- S001
- 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
- 2024-09-27
- Decision date
- 2024-10-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lake Forest, CA
- Statement
- Approval to implement the following manufacturing changes to UNIFEYE and UNIPEXY Gas Delivery Systems: 1) Implementing a pre- and post-assembly weight verification for UNIFEYE and UNIPEXY Gas Delivery Systems; 2) Implementing weighing cradles for UNIFEYE and UNIPEXY Gas Delivery Systems; 3) Updating the fixture travel length for the UNIFEYE Gas Delivery System during the insertion of the mixture stop into the plunger body. A new calibrated distance gauge will be used to verify this travel length
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |