510(k) K173771

IOLMaster 700 by Carl Zeiss Meditec, AG — Product Code HJO

K173771 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "IOLMaster 700". The FDA issued a decision of Substantially Equivalent on August 24, 2018. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2018
Date Received
December 11, 2017
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