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FDA 510(k)

UNITY VCS (8065000296); UNITY CS (8065000297)

K-Number: K233876 · 2024-06-21

ApplicantAlcon Laboratories, Inc.
Decision Date2024-06-21
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNITY VCS (8065000296); UNITY CS (8065000297) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233876. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITY VCS (8065000296); UNITY CS (8065000297)?

UNITY VCS (8065000296); UNITY CS (8065000297) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K233876.

When did UNITY VCS (8065000296); UNITY CS (8065000297) receive FDA 510(k) clearance?

UNITY VCS (8065000296); UNITY CS (8065000297) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233876.

Who is the listed applicant for UNITY VCS (8065000296); UNITY CS (8065000297)?

The FDA 510(k) record lists Alcon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITY VCS (8065000296); UNITY CS (8065000297)?

The FDA product code for UNITY VCS (8065000296); UNITY CS (8065000297) is HQC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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