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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 K161046
Device Name Laser Helmet LH40-EVO
Applicant
Theradome, Inc
4900 Hopyard Road, Suite 100
Pleasanton,  CA  94588
Applicant Contact Tamim Hamid
Correspondent
Theradome, Inc
4900 Hopyard Road, Suite 100
Pleasanton,  CA  94588
Correspondent Contact Vern Liebmam
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/13/2016
Decision Date 05/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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