The following data is part of a premarket notification filed by Kam Yuen Plastic Products Ltd. with the FDA for Aimanfun Lumea Comfort, A-2789/a-3588.
| Device ID | K212907 |
| 510k Number | K212907 |
| Device Name: | Aimanfun Lumea Comfort, A-2789/A-3588 |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Kam Yuen Plastic Products Ltd. No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town Zhongshan, CN 518100 |
| Contact | Anna Dan |
| Correspondent | Jett Lee Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2021-12-02 |