Identifiers
- 510(k) Number
- K212024 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 PAL System is a power-assisted liposuction device designed for the removal of subcutaneous fat through suction-assisted techniques. Classified as a suction, lipoplasty device for fat removal, it is intended for use in plastic surgery procedures to contour body areas by aspirating adipose tissue with controlled precision.
The system is supplied as a reusable medical device and is intended for use in sterile surgical environments. It includes a handpiece (e.g., PAL-750) and associated components for fat extraction, with no specific MRI safety restrictions noted. The device is cleared under FDA 510(k) (K212024) and falls under regulation number 878.5040, categorized under product code QPB for suction, lipoplasty systems.
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: PAL System and Accessories - MicroAire Surgical Instruments, LLC., MicroAire Surgical Instruments, LLC., Pal® Power-assisted Liposuction System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212024 | Class II | Active |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
- FDA Applicant
- Microaire Surgical Instruments, LLC
Sources (1)
- FDA 510(k) K212024 24 fields · synced Sep 19, 2026