510(k) K182646

Vitreq disposable laser probes, light fibers and Chandelier by Vitreq BV — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2019
Date Received
September 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type