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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K871031
Device Name 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
Applicant
Directed Energy, Inc.
11661 San Vicente Blvd.
Suite 203
Los Angeles,  CA  90049
Applicant Contact EDWARD JOHANSEN
Correspondent
Directed Energy, Inc.
11661 San Vicente Blvd.
Suite 203
Los Angeles,  CA  90049
Correspondent Contact EDWARD JOHANSEN
Regulation Number878.4810
Classification Product Code
LNK  
Date Received03/16/1987
Decision Date 05/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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