Cleared Traditional

K244026 - PAL 7020 Console

K244026 is an FDA 510(k) clearance for PAL 7020 Console, manufactured by Microaire Surgical Instruments, LLC. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K244026 · Microaire Surgical Instruments, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
116d
Days
Class 2
Risk

K244026 is an FDA 510(k) clearance for the PAL 7020 Console. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Microaire Surgical Instruments, LLC devices

FDA 510(k) Submission Details - K244026

510(k) Number K244026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2024
Decision Date April 25, 2025
Days to Decision 116 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPB Device Classification - Class 2, Special Controls

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 23
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K244026.
AYON Body Contouring System™ (AYON SYSTEM)
K253396 · Apyx Medical Corporation · May 2026
LSSA (NP-200)
K252495 · Newpong Co., Ltd. · Apr 2026
AYON Body Contouring System (AYON SYSTEM)
K244050 · Apyx Medical Corporation · May 2025
PAL Aspiration System
K242804 · Microaire Surgical Instruments, LLC · Dec 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835 · Cellmyx · Nov 2024
Vitruvian Liposaber
K240188 · Black & Black Surgical, Inc. · Sep 2024