FDA.reportPublic FDA data

510(k) K242184

Device
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
Applicant
Alcon Laboratories, Inc.
510(k) number
K242184
Product code
MPA
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-04
Date received
2024-07-25
Regulation
876.1500
Classification name
Endoilluminator
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ganesh Balachandar
Address
6201 S. Fwy. Fort Worth TX US 76134 76134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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