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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K113097
Device Name LASER HELMET
Applicant
Theradome, Inc.
1001 Bear Island Rd., Suite 136
Summerville,  SC  29483
Applicant Contact LARRY PETERSEN
Correspondent
Theradome, Inc.
1001 Bear Island Rd., Suite 136
Summerville,  SC  29483
Correspondent Contact LARRY PETERSEN
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Code
NHN  
Date Received10/19/2011
Decision Date 03/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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