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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 K180460
Device Name Theradome LH40
Applicant
Theradome, Inc.
4900 Hopyard Road, Suite 100
Pleasanton,  CA  94588
Applicant Contact Tamim Hamid
Correspondent
Jacqueline A. Hauge
23300 Manning Trail N
Scandia,  MN  55073
Correspondent Contact Jacqueline A. Hauge
Regulation Number890.5500
Classification Product Code
OAP  
Date Received02/20/2018
Decision Date 05/18/2018
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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