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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K870841
Device Name MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
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 Number884.4550
Classification Product Code
HHR  
Date Received02/26/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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