510(k) K813313

BIOMICROSCOPY CONTACT LENS by Design Research Assoc., Inc. — Product Code HJO

K813313 is an FDA 510(k) premarket notification submitted by Design Research Assoc., Inc. for the device "BIOMICROSCOPY CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Design Research Assoc., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
November 24, 1981
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