The following data is part of a premarket notification filed by Kunshan Bella Optical Technology Co., Ltd. with the FDA for Hair Growth System.
| Device ID | K191754 |
| 510k Number | K191754 |
| Device Name: | Hair Growth System |
| Classification | Laser, Comb, Hair |
| Applicant | Kunshan Bella Optical Technology Co., Ltd. Plant 2, Kunshan Development Zone, No. 218 Cheng Hu Road Kunshan, CN 215300 |
| Contact | Wu Xuefeng |
| Correspondent | Wu Xuefeng Kunshan Bella Optical Technology Co., Ltd. Plant 2, Kunshan Development Zone, No. 218 Cheng Hu Road Kunshan, CN 215300 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-11-22 |