510(k) K884241

STAAR PHACO XL SMALL INCISION SYSTEM by Staar Surgical Co. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
October 11, 1988
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