The following data is part of a premarket notification filed by Infinitus (china) Company Ltd. with the FDA for Benelife Premium Facial Treatment Pack, Model: Qz0701a.
| Device ID | K171647 |
| 510k Number | K171647 |
| Device Name: | BeneLife Premium Facial Treatment Pack, Model: QZ0701A |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Infinitus (China) Company Ltd. 17/F, Infinitus Centre, No.12 Zhujiang West Rd., Tianhe Dist Guangzhou, CN |
| Contact | Judy Zhou |
| 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 | 2017-06-05 |
| Decision Date | 2017-10-23 |
| Summary: | summary |