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/t1, T2, T3.
| Device ID | K172883 |
| 510k Number | K172883 |
| Device Name: | Home Use Hair Removal Device/T1, T2, T3 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Mareal Tech Co., Ltd 403A Block, Xinlong Technology Park, No.50 Fengtang Road Xintian Community, Fuyong Town, Bao'an District Shenzhen, CN |
| Contact | Libin Liu |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road 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 | 2017-09-21 |
| Decision Date | 2018-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970275250100 | K172883 | 000 |
| 06970275250094 | K172883 | 000 |
| 06970275250087 | K172883 | 000 |