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, Model(s): Ms-208b, Ms-212b, Ms-216b, Ms-218b, Melsya-m6, Melsya-m7..
| Device ID | K210311 |
| 510k Number | K210311 |
| Device Name: | Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Mismon Technology Co., Ltd. 4th Floor, Building B, Zone A, Longquan Technology Park, Tongfuyu Phase2, Tongsheng Community Shenzhen, CN 518000 |
| Contact | Rain Yip |
| Correspondent | Rain Yip Shenzhen Mismon Technology Co., Ltd. 4th Floor, Building B, Zone A, Longquan Technology Park, Tongfuyu Phase2, Tongsheng Community 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 | 2021-02-03 |
| Decision Date | 2021-07-23 |