The following data is part of a premarket notification filed by Kam Yuen Plastic Products Ltd with the FDA for Aimanfun Lumea Comfort.
| Device ID | K190820 |
| 510k Number | K190820 |
| Device Name: | Aimanfun Lumea Comfort |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Kam Yuen Plastic Products Ltd No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town Zhongshan, CN |
| Contact | Anna Dan |
| Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-10-02 |