The following data is part of a premarket notification filed by Li-tek Electronic Technology Corporation with the FDA for Micro-current Wrinkle Reduction Facial Service, Model Ep-400.
| Device ID | K162106 |
| 510k Number | K162106 |
| Device Name: | Micro-current Wrinkle Reduction Facial Service, Model EP-400 |
| 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 |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2017-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00031262096531 | K162106 | 000 |