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FDA 510(k)

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

K-Number: K242184 · 2024-12-04

ApplicantAlcon Laboratories, Inc.
Decision Date2024-12-04
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); 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 2024-12-04 under 510(k) number K242184. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K242184.

When did Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); receive FDA 510(k) clearance?

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242184.

Who is the listed applicant for Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

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 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);?

The FDA product code for Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); is MPA.

Other records listing Alcon Laboratories, Inc. as applicant

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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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