Powersculp Laser Lipolysis System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191068 FDA 510(k)
- FDA Product Code
- PKT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5400 FDA 510(k)
- Regulation Number
- 878.5400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Powersculp Laser Lipolysis System is a laser device classified for the disruption of adipocyte cells for aesthetic use. It employs laser technology to selectively target and reduce localized fat deposits, enabling non-invasive body contouring procedures for areas such as the abdomen, thighs, and arms. The device facilitates the breakdown of fat cells through controlled laser energy, promoting their natural elimination by the body.
The Powersculp Laser Lipolysis System is a reusable medical device regulated under 21 CFR 878.5400 as a Low Level Laser System. It is intended for use in clinical settings by trained professionals, such as plastic surgeons or dermatologists, and requires proper maintenance and sterilization between procedures. No specific MRI safety information is provided, but its use must comply with standard laser safety protocols. The device received FDA 510(k) clearance (K191068) through the Traditional 510(k) pathway.
Powersculp Laser Lipolysis System
Frequently asked questions
What is the Powersculp Laser Lipolysis System used for?
The Powersculp Laser Lipolysis System is designed for aesthetic use to disrupt adipocyte (fat) cells in targeted areas like the abdomen, thighs, and arms. It employs controlled laser energy to break down fat deposits, enabling the body to naturally eliminate them for non-invasive body contouring. This procedure is performed by trained professionals such as plastic surgeons or dermatologists in clinical settings.
How is the Powersculp Laser Lipolysis System supplied and maintained?
The Powersculp Laser Lipolysis System is a reusable medical device, meaning it is intended for repeated use in clinical environments. Proper maintenance and sterilization between procedures are required to ensure safety and efficacy. Users must follow manufacturer guidelines for cleaning, disinfection, and storage to comply with regulatory standards and prevent cross-contamination.
Is the Powersculp Laser Lipolysis System single-use or reusable?
The Powersculp Laser Lipolysis System is explicitly designed as a reusable device. Unlike single-use instruments, it is intended for multiple procedures with appropriate maintenance and sterilization between uses. This classification aligns with its classification under 21 CFR 878.5400 as a Low Level Laser System, requiring adherence to sterilization protocols to maintain performance and safety.
What safety considerations apply to the Powersculp Laser Lipolysis System?
The Powersculp Laser Lipolysis System must be used in compliance with standard laser safety protocols, though specific MRI safety information is not provided. Since it is classified as a Low Level Laser System under 21 CFR 878.5400, its use is restricted to trained professionals in clinical settings. Proper training, adherence to manufacturer instructions, and adherence to regulatory guidelines are essential to minimize risks such as tissue damage or improper energy delivery.
What regulatory pathway was followed for the Powersculp Laser Lipolysis System?
The Powersculp Laser Lipolysis System received FDA 510(k) clearance (K191068) through the Traditional 510(k) pathway, demonstrating that it is substantially equivalent to a legally marketed predicate device. This pathway involves a review by the FDA to ensure the device’s safety and effectiveness for its intended use—non-invasive fat reduction for aesthetic purposes—before commercial distribution.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K191068 FDA 510 (k) - Powersculp laser lipolysis system, Powersculp laser lipolysis system (K191068) — FDA 510 (k) | Innolitics, Powersculp laser lipolysis system - FDA 510(k) K191068
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191068 | Class II | Active |
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Manufacturer
- Manufacturer
- Wuhan Lotuxs Technology Co., Ltd.
Sources (1)
- FDA 510(k) K191068 24 fields · synced Oct 1, 2026