The following data is part of a premarket notification filed by Shenzhen Mywin Technology Co., Ltd. with the FDA for Ipl Hair Remover, Model: G993, G996, G998 And G885.
| Device ID | K221679 |
| 510k Number | K221679 |
| Device Name: | IPL Hair Remover, Model: G993, G996, G998 And G885 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Mywin Technology Co., Ltd. 2nd Floor, Building B, New Age Gongrong Industrial Zone, No. 2, Shihuan Road, Shilong Communit Shenzhen, CN |
| Contact | Meiyun Liu |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-07-07 |