The following data is part of a premarket notification filed by Shenzhen Gsd Tech. Co., Ltd. with the FDA for Diode Laser Hair Removal System.
| Device ID | K142186 |
| 510k Number | K142186 |
| Device Name: | DIODE LASER HAIR REMOVAL SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SHENZHEN GSD TECH. CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN GSD TECH. CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2015-04-17 |
| Summary: | summary |