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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K171821
Device Name 2 Face / Face Evolution
Applicant
Heat IN A Click
1975 Tigertail Blvd. Dania
Homestead,  FL  33034
Applicant Contact Guy Levi
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd.
Guangzhou Science Park
Guangzhou,  CN 510006
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Codes
OHS   OLP  
Date Received06/19/2017
Decision Date 04/26/2018
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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