The following data is part of a premarket notification filed by Beijing Sano Laser S&t Development Co., Ltd with the FDA for Diode Laser Hair Removal System.
| Device ID | K191970 |
| 510k Number | K191970 |
| Device Name: | Diode Laser Hair Removal System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing Sano Laser S&T Development Co., Ltd Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District Bejing, CN |
| Contact | Hongbo Zhang |
| Correspondent | Huifang Zhao Microkn Business Consulting (Shanghai)Co., Ltd Room 1319, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, CN 200435 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-24 |
| Decision Date | 2020-04-06 |