Cleared Traditional

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

K242184 · Alcon Laboratories, Inc. · Ophthalmic
Dec 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K242184 is an FDA 510(k) clearance for the Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Alcon Laboratories, Inc. (Fort Worth,, US). The FDA issued a Cleared decision on December 4, 2024, 132 days after receiving the submission on July 25, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K242184 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2024
Decision Date December 04, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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