Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041058 FDA 510(k)
- FDA Product Code
- QPB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5040 FDA 510(k)
- Regulation Number
- 878.5040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems are medical devices used for suction in lipoplasty procedures. They are designed to provide ultrasonic surgical aspiration. The systems are classified as a type of suction system for removal in lipoplasty procedures.
The Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems are supplied with various components and are intended for use in surgical settings. They have been cleared by the FDA under the 510K clearance process, with a regulation number of 878.5040. The devices are manufactured by Misonix, Inc. and have a product code of QPB.
Frequently asked questions
What is the Lysonix 2000/3000 used for?
The Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems are used for suction in lipoplasty procedures, providing ultrasonic surgical aspiration.
How are the Lysonix 2000/3000 systems supplied?
The systems are supplied with various components and are intended for use in surgical settings.
What is the regulatory status of the Lysonix 2000/3000 systems?
The devices have been cleared by the FDA under the 510K clearance process, with a regulation number of 878.5040.
What type of settings are the Lysonix 2000/3000 systems intended for?
The Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems are intended for use in surgical settings, specifically for lipoplasty procedures.
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: MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS by ..., PDF K041058 Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator ..., Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems ..., Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041058 | Class II | Active |
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Manufacturer
- Manufacturer
- Misonix, Inc.
Sources (1)
- FDA 510(k) K041058 24 fields · synced Sep 28, 2026