The following data is part of a premarket notification filed by Kam Yuen Plastic Products Ltd. with the FDA for Laser Hair Growth Helmet.
| Device ID | K213025 |
| 510k Number | K213025 |
| Device Name: | Laser Hair Growth Helmet |
| Classification | Laser, Comb, Hair |
| Applicant | Kam Yuen Plastic Products Ltd. No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town Zhongshan, CN 528400 |
| Contact | Anna Dan |
| Correspondent | Jett Lee Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-05-12 |