The following data is part of a premarket notification filed by Shenzhen Ionka Medical Technology Co., Ltd. with the FDA for Hand-held Ipl Device (ipl Home Use Hair Removal Device) Model:fz-608, Fz-608g, Fz-100, Fz-200.
| Device ID | K221214 |
| 510k Number | K221214 |
| Device Name: | Hand-held IPL Device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Shenzhen IONKA Medical Technology Co., Ltd. Room 601, No. 3, Jiazitang Second Industrial Zone, Fenghuang Street, Guangming District Shenzhen, CN 518123 |
| Contact | Chen Dongfa |
| Correspondent | Amos Zou Shenzhen CT Bio-Tech Co., Ltd Room 408, Comprehensive Building, Building 6, Xusheng Building, Xixiang Street, Baoan District Shenzhen, CN 518126 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-09-21 |