510(k) K233876

UNITY VCS (8065000296); UNITY CS (8065000297) by Alcon Laboratories, Inc. — Product Code HQC

K233876 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "UNITY VCS (8065000296); UNITY CS (8065000297)". The FDA issued a decision of Substantially Equivalent on June 21, 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
June 21, 2024
Date Received
December 7, 2023
Clearance Type
Traditional
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