The following data is part of a premarket notification filed by Guangzhou Chuang Zao Mei Technology Co., Ltd with the FDA for Diode Laser Hair Removal Device.
| Device ID | K221312 |
| 510k Number | K221312 |
| Device Name: | Diode Laser Hair Removal Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Guangzhou CHUANG ZAO MEI Technology Co., Ltd Dehe International A505, No.2, Qixinggang Industrial Road, JUNHE Street, Baiyun District Guangzhou, CN 510440 |
| Contact | Karpov Aleksandr |
| Correspondent | Asher No Last Name Provided AskWay Innovative Ltd. 4F, Yuehuayuan Building, 2008 Nanshan Avenue, Nanshan Street Nashan District Shenzhen, CN 518000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-05 |
| Decision Date | 2022-06-29 |