510(k) K993357

IOLMASTER by Carl Zeiss, Inc. — Product Code HJO

K993357 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "IOLMASTER". The FDA issued a decision of Substantially Equivalent on March 20, 2000. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2000
Date Received
October 6, 1999
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