510(k) K131711

YZ3 PORTABLE SLIT LAMP by Suzhou 66 Vision Tech Co., Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2014
Date Received
June 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type