The following data is part of a premarket notification filed by Li-tek Electronic Technology Corporation with the FDA for Smart Photon Micro-current Device, Model: Ep-300.
| Device ID | K162652 |
| 510k Number | K162652 |
| Device Name: | Smart Photon Micro-current Device, Model: EP-300 |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | LI-TEK ELECTRONIC TECHNOLOGY CORPORATION NO.8-13, THE INDUSTRIAL PARK OF JINSHAGANG, SHIXIAVILLAGE, DALANGTOWN Dongguan, CN |
| Contact | Barry Yuan |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | NFO |
| Subsequent Product Code | OHS |
| Subsequent Product Code | OLP |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-23 |
| Decision Date | 2017-10-25 |
| Summary: | summary |