510(k) K171647
K171647 is an FDA 510(k) premarket notification submitted by Infinitus (China) Company , Ltd. for the device "BeneLife Premium Facial Treatment Pack, Model: QZ0701A". The FDA issued a decision of Substantially Equivalent on Oct 23, 2017. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2017
- Date Received
- Jun 5, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)