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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 K173678
Device Name Diode Laser Cap
Applicant
Cosmo Far East Technology Limited
Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue
Songgang, Bao'an District
Shenzhen,  CN 518000
Applicant Contact Bob An
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number890.5500
Classification Product Code
OAP  
Date Received11/30/2017
Decision Date 02/28/2018
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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