The following data is part of a premarket notification filed by Shenzhen Mareal Tech Co., Ltd with the FDA for Home Use Hair Removal Device.
| Device ID | K220248 |
| 510k Number | K220248 |
| Device Name: | Home Use Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Mareal Tech Co., Ltd 301,Building 1,No.2,Xiashiwei Road,Huaide Community, Fuyong Street, Baoan District Shenzhen, CN 518000 |
| Contact | Liu Libin |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road, Nanshan District 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 | 2022-01-31 |
| Decision Date | 2022-07-01 |