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 Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/23/2016 |
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
|
|
|