510(k) K233902

Centurion™ Vision System (Active Sentry™) (8065753057) by Alcon Laboratories, Inc. — Product Code HQC

K233902 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "Centurion™ Vision System (Active Sentry™) (8065753057)". The FDA issued a decision of Substantially Equivalent on January 10, 2024. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2024
Date Received
December 11, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type