Cleared Traditional

PAL System

K212024 · Microaire Surgical Instruments, LLC · General & Plastic Surgery

Jun 2022

Decision

346d

Days

Class 2

Risk

About This 510(k) Submission

K212024 is an FDA 510(k) clearance for the PAL System, a System, Suction, Lipoplasty For Removal (Class II — Special Controls, product code QPB), submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on June 10, 2022, 346 days after receiving the submission on June 29, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.

Submission Details

510(k) Number	K212024 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2021
Decision Date	June 10, 2022
Days to Decision	346 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	QPB — System, Suction, Lipoplasty For Removal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5040
Definition	A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring