510(k) K131567

ALADDIN by Visia Imaging S.R.L. — Product Code HJO

K131567 is an FDA 510(k) premarket notification submitted by Visia Imaging S.R.L. for the device "ALADDIN". The FDA issued a decision of Substantially Equivalent on June 5, 2014. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Visia Imaging S.R.L. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2014
Date Received
May 30, 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