The following data is part of a premarket notification filed by Shenzhen Cosbeauty Technology Co., Ltd. with the FDA for Lllt Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210..
| Device ID | K213447 |
| 510k Number | K213447 |
| Device Name: | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. |
| Classification | Laser, Comb, Hair |
| Applicant | Shenzhen CosBeauty Technology Co., Ltd. UnitA-3F, Qiao De Industrial Park, Tian Liao Guang Ming District Shenzhen, CN 518000 |
| Contact | Ares Zou |
| Correspondent | Tracy Che Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road, Shenzhen, CN 518052 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-25 |
| Decision Date | 2022-01-19 |