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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K100116
FOIA Releasable 510(k) K100116
Device Name LASERTOUCHONE (OTC)
Applicant
Laser Health Technologies, LLC
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Laser Health Technologies, LLC
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NHN  
Date Received01/15/2010
Decision Date 04/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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