510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041058Substantially Equivalent

Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems

Misonix, LLC, Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041058 is the FDA 510(k) clearance record for MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS, a class II device, cleared for Misonix, Inc. on under FDA product code QPB (System, Suction, Lipoplasty For Removal). FDA's definition for product code QPB reads: "A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring". FDA records list 18 510(k) clearances for Misonix, Inc., from to . As of , FDA records show one recall naming K041058.

Clearance record

Decision date
Received
(24 days to decision)
Product code
QPB System, Suction, Lipoplasty For Removal
Regulation
21 CFR 878.5040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Misonix, Inc. 1938 New Hwy., Farmingdale NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPB

Trailing 12 months
5 clearances under product code QPB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260