DeviceClearance

Lipocosm Harmonic System— 510(k) K251944

Substantially Equivalent

Lipocosm, LLC

FDA 510(k) clearance K251944 for Lipocosm Harmonic System, Substantially Equivalent on 2026-06-08. Applicant: Lipocosm, LLC. Device class: 2.

Summary

Lipocosm's Lipocosm Harmonic System is filed under QPB, suction lipoplasty systems for removal. The record doesn't describe the system beyond its name and the code name.

Class II, 21 CFR 878.5040. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

Lipocosm filed from Key Biscayne, Florida. Review took 349 calendar days (June 24, 2025 to June 8, 2026).

Clearance details

Applicant
Lipocosm, LLC
Product code
Product code QPB
Device class
Class 2
Regulation
21 CFR 878.5040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Key Biscayne, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.