The following data is part of a premarket notification filed by Zhengzhou Pz Laser Slim Technology Co., Ltd with the FDA for Diode Laser Hair Removal Device.
| Device ID | K180353 |
| 510k Number | K180353 |
| Device Name: | Diode Laser Hair Removal Device |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zhengzhou PZ Laser Slim Technology Co., Ltd Fl 2th, Jia Tu Zhi Ye Intersection Of Hong Song Road And Lian Hua Road High-tech Development Zone, Zhengzhou, CN 450001 |
| Contact | Zhou Hongwei |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-04-17 |
| Summary: | summary |