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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ent Microsurgical Carbon-Dioxide
510(k) Number K862865
Device Name MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
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 Number874.4500
Classification Product Code
EWG  
Date Received07/29/1986
Decision Date 01/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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