The following data is part of a premarket notification filed by Shenzhen Mismon Technology Co., Ltd with the FDA for Home Use Ipl Beauty Device.
| Device ID | K180016 |
| 510k Number | K180016 |
| Device Name: | Home Use IPL Beauty Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Mismon Technology Co., Ltd 2nd Floor, A2 Building, Zhengfeng Industrial Park No.610 Fengtang Road, Fuyon Shenzhen, CN 518000 |
| Contact | Vicky Yang |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road, S 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 | 2018-01-02 |
| Decision Date | 2018-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971648210011 | K180016 | 000 |