The following data is part of a premarket notification filed by Shenzhen Semlamp Intelligent Technology Co., Ltd with the FDA for Ipl Hair Removal (model: Sl-b080, Sl-b126, Sl-b136).
| Device ID | K221246 |
| 510k Number | K221246 |
| Device Name: | IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Semlamp Intelligent Technology Co., Ltd Room 915, Lankun Building, Minkang Road 213, Zhangkeng Community, Minzhi Avenue, Longhua Shenzhen, CN 518131 |
| Contact | Qi Wenjun |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510530 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-07-07 |