510(k) K242184

Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); by Alcon Laboratories, Inc. — Product Code MPA

K242184 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);". The FDA issued a decision of Substantially Equivalent on December 4, 2024. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2024
Date Received
July 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type