The following data is part of a premarket notification filed by Shen Zhen Cosbeauty Co.,ltd. with the FDA for Perfectsmooth.
Device ID | K161428 |
510k Number | K161428 |
Device Name: | PerfectSmooth |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | SHEN ZHEN COSBEAUTY CO.,LTD. UNIT A- 3F, QIAO DE INDUSTRIAL PARK, TIAN LIAO, GUANG MING GUANG MING DISTRICT Shenzhen, CN 518000 |
Contact | Nicole Hu |
Correspondent | Yuchen Che FEIYING DRUG & MEDICAL CONSULTING TECHNICAL SERVICE GROUP RM.3005, AREA B, BLDG.1, SOUTHWARD RUIFENG BUSINESS CENTER, GUIMIAO RD Shenzhen, CN 518000 |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-23 |
Decision Date | 2017-03-23 |
Summary: | summary |