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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 K122950
Device Name LASER HELMET
Applicant
THERADOME INC.
4900 HOPYARD ROAD
SUITE 100
PLEASANTON,  CA  94588
Applicant Contact LARRY PETERSEN
Correspondent
THERADOME INC.
4900 HOPYARD ROAD
SUITE 100
PLEASANTON,  CA  94588
Correspondent Contact LARRY PETERSEN
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/25/2012
Decision Date 06/14/2013
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
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