Submission Details
| 510(k) Number | K161794 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 2016 |
| Decision Date | April 14, 2017 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CENTURION Vision System (Active SentryTM)
Apr 2017
Decision
288d
Days
Class 2
Risk
About This 510(k) Submission
K161794 is an FDA 510(k) clearance for the CENTURION Vision System (Active SentryTM), a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on April 14, 2017, 288 days after receiving the submission on June 30, 2016. 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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