K242184 is an FDA 510(k) clearance for the Alcon 27GA Chandelier (8065000252). This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 4, 2024, 132 days after receiving the submission on July 25, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K242184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2024 |
| Decision Date | December 04, 2024 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA — Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |