510(k) K831231

LED GOGGLES by Cadwell Laboratories, Inc. — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 15, 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