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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K180900
Device Name LED Light Therapy Device
Applicant
Uvbiotek, LLC
3 Depot St., Hudson Falls
New York,  NY  12839
Applicant Contact Dave Oberhelman
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 215, Huaming Bldg., Chebei Rd.
Guangzhou,  CN 511660
Correspondent Contact Jinghua Zhou
Regulation Number878.4810
Classification Product Code
OLP  
Date Received04/06/2018
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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