510(k) K063750

XCEL 255 SLIT LAMP by Reichert, Inc. — Product Code HJO

K063750 is an FDA 510(k) premarket notification submitted by Reichert, Inc. for the device "XCEL 255 SLIT LAMP". The FDA issued a decision of Substantially Equivalent on December 20, 2006. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Reichert, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2006
Date Received
December 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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