510(k) K190269
K190269 is an FDA 510(k) premarket notification submitted by Xtreem Pulse, LLC for the device "PureLift". The FDA issued a decision of Substantially Equivalent on August 28, 2019. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Xtreem Pulse, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2019
- Date Received
- February 8, 2019
- 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