The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Laser-stim.
| Device ID | K131259 |
| 510k Number | K131259 |
| Device Name: | LASER-STIM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Jiangping Kang |
| Correspondent | Jiangping Kang SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-02 |
| Decision Date | 2013-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237621055 | K131259 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASER-STIM 75010967 2102016 Live/Registered |
LASERSTIM, INC. 1995-10-26 |