The following data is part of a premarket notification filed by Liaoning Sidey Optoelectronics Technologies Co., Ltd. with the FDA for Handheld Diode Laser For Hair Removal.
| Device ID | K163173 |
| 510k Number | K163173 |
| Device Name: | Handheld Diode Laser For Hair Removal |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Liaoning Sidey Optoelectronics Technologies Co., Ltd. No.6 Building,No.262 Yueling Rd. High-Tech Industrial Development Zone Anshan, CN 114044 |
| Contact | Li Zhao |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou Beijing, CN 101121 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-02-08 |
| Summary: | summary |