Submission Details
| 510(k) Number | K233902 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 2023 |
| Decision Date | January 10, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
Centurion? Vision System (Active Sentry?) (8065753057)
Jan 2024
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K233902 is an FDA 510(k) clearance for the Centurion? Vision System (Active Sentry?) (8065753057), a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Laboratories, Inc. (Fort Worth,, US). The FDA issued a Cleared decision on January 10, 2024, 30 days after receiving the submission on December 11, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.
Device Classification
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
Manufacturer
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