510(k) K833446

DOWNING SPECTRAL ILLUMINATOR by Vision Health Technology — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
October 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
Submission Type