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 |