PAL System— 510(k) K212024

Substantially Equivalent

Microaire Surgical Instruments, LLC

FDA 510(k) clearance K212024 for PAL System, Substantially Equivalent on 2022-06-10. Applicant: Microaire Surgical Instruments, LLC. Device class: 2.

Clearance details

Applicant: Microaire Surgical Instruments, LLC
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2021-06-29
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPB

K254135 — LipoSurg ARTIST2026-09-05
K261710 — AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors2026-08-21
K251944 — Lipocosm Harmonic System2026-06-08
K253396 — AYON Body Contouring System (AYON SYSTEM)2026-05-08
K252495 — LSSA (NP-200)2026-04-03

More clearances from Microaire Surgical Instruments, LLC

K243589 — PAL Sterilization Case2025-06-20
K244026 — PAL 7020 Console2025-04-25
K242804 — PAL Aspiration System2024-12-30
K220318 — PAL Infiltration System2022-10-14
K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System2018-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.