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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K870839
Device Name MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
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 Number886.4390
Classification Product Code
HQF  
Date Received02/25/1987
Decision Date 05/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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