The following data is part of a premarket notification filed by Shenzhen Desida Technology Co., Ltd. with the FDA for Hair Removal Device (model: Ipl-d26, Ipl-d19).
| Device ID | K221643 |
| 510k Number | K221643 |
| Device Name: | Hair Removal Device (Model: IPL-D26, IPL-D19) |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Desida Technology Co., Ltd. 5F, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoan Shenzhen, CN 518109 |
| Contact | Gong Yong |
| Correspondent | Amos Zou Shenzhen CT Bio-Tech Co., Ltd. Room 408, Comprehensive Building, Building 6, Xusheng Building, Xixiang Street, Baoan District Shenzhen, CN 518102 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-10-21 |