The following data is part of a premarket notification filed by Shenzhen Accompany Technology Co., Ltd. with the FDA for Red Wave Hair Removal.
| Device ID | K212099 |
| 510k Number | K212099 |
| Device Name: | Red Wave Hair Removal |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Shenzhen Accompany Technology Co., Ltd. Unit. 375, Xiangnan Ruifeng Gradan, No. 22, Guimiao Road, Xuefu Community, Nanshan Street, Nanshan District Shenzhen, CN |
| Contact | Yourong Lai |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2021-09-24 |