The following data is part of a premarket notification filed by Shandong Huamei Technology Co.,ltd. with the FDA for Diode Laser Hair Removal System.
| Device ID | K162659 |
| 510k Number | K162659 |
| Device Name: | Diode Laser Hair Removal System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHANDONG HUAMEI TECHNOLOGY CO.,LTD. 588, CHANGNING ST, HIGH-TECH DISTRICT Weifang, CN 261000 |
| Contact | Xu Qinghua |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing Beijing, CN 101121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973512860131 | K162659 | 000 |
| 06973512860124 | K162659 | 000 |
| 06973512860117 | K162659 | 000 |
| 06973512860162 | K162659 | 000 |
| 06973512860155 | K162659 | 000 |
| 06973512860148 | K162659 | 000 |
| 06973512860179 | K162659 | 000 |