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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light based over-the-counter hair removal
510(k) Number K161428
Device Name PerfectSmooth
Applicant
SHEN ZHEN COSBEAUTY CO.,LTD.
UNIT A- 3F, QIAO DE INDUSTRIAL PARK, TIAN LIAO, GUANG MING
GUANG MING DISTRICT
shenzhen,  CN 518000
Applicant Contact nicole hu
Correspondent
FEIYING DRUG & MEDICAL CONSULTING TECHNICAL SERVICE GROUP
RM.3005, AREA B, BLDG.1, SOUTHWARD RUIFENG BUSINESS CENTER,
GUIMIAO RD
shenzhen,  CN 518000
Correspondent Contact yuchen che
Regulation Number878.4810
Classification Product Code
OHT  
Date Received05/23/2016
Decision Date 03/23/2017
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
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