PowerX Lipo System
510(k) K190555
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190555 | Date1 May 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QPB
- Device class
- Class II
- Regulation
- 21 CFR Part 878.5040
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PowerX Lipo System is a suction-based lipoplasty device designed for the removal of subcutaneous fat through controlled suction techniques. Classified as a Suction, Lipoplasty for Removal system, it is intended for use in cosmetic and plastic surgery procedures to reshape body contours by selectively eliminating excess fat deposits.
This device is supplied as a reusable medical system and is regulated under FDA 510(k) clearance (K190555) as a Class II device under regulation number 878.5040. It is intended for use in clinical settings by trained professionals, with no specific sterility requirements stated beyond standard surgical protocols. The system includes multiple component parts referenced by FEI numbers, indicating compatibility with various cannula and suction attachments for different procedural needs.
Other devices from Solta Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PowerX Lipo System used for?
The PowerX Lipo System is designed for controlled suction-based lipoplasty, a procedure used in cosmetic and plastic surgery to remove subcutaneous fat and reshape body contours. It selectively targets excess fat deposits to achieve smoother, more defined contours, typically in clinical settings by trained professionals.
Is the PowerX Lipo System reusable or single-use?
The PowerX Lipo System is supplied as a reusable medical device. While the system itself is intended for repeated use, individual components like cannulas and attachments may vary in their intended use (e.g., single-use or reusable), depending on the specific FEI-numbered part referenced in the system. Always follow manufacturer guidelines for each component.
What types of cannulas and attachments are compatible with the PowerX Lipo System?
The PowerX Lipo System is compatible with a variety of cannula and suction attachments, each identified by unique FEI numbers (e.g., 3004112621, 1000518699). These attachments are designed to accommodate different procedural needs, such as varying fat deposit locations or patient anatomies. The system’s modular design allows for flexibility in selecting the appropriate tools for specific lipoplasty techniques.
Are there any specific sterility requirements for the PowerX Lipo System?
The PowerX Lipo System does not specify unique sterility requirements beyond standard surgical protocols. As a reusable device intended for clinical use, it must be cleaned, disinfected, and sterilized according to established medical device reprocessing guidelines to ensure patient safety and device integrity between procedures.
How is the PowerX Lipo System regulated in the U.S.?
The PowerX Lipo System is regulated under FDA 510(k) clearance (K190555) as a Class II device under regulation number 878.5040. This classification indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the requirements for safety and effectiveness as outlined by the FDA. The system falls under the product code QPB for Suction, Lipoplasty for Removal.