Submission Details
| 510(k) Number | K233876 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
UNITY VCS (8065000296); UNITY CS (8065000297)
Jun 2024
Decision
197d
Days
Class 2
Risk
About This 510(k) Submission
K233876 is an FDA 510(k) clearance for the UNITY VCS (8065000296); UNITY CS (8065000297), 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 June 21, 2024, 197 days after receiving the submission on December 7, 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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