QPBClass II

System, Suction, Lipoplasty For Removal

General, Plastic Surgery · 21 CFR 878.5040

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

MDR events69All time

Recalls1All time

Registered firms80Currently listed

510(k) clearances58All time

Recent MDR events

69 adverse event reports on file

Event type breakdown

Injury64

Malfunction5

Most-reported manufacturers

Solta Medical, Inc34 Solta Medical, Inc.14 Solta Medical Inc.6 Microaire Surgical Instruments Llc3 Solta Medical Inc3 Unknown2 Apyx Medical Corporation1 Euromi Sa1

Recalls

1 recall events for this product code

HUMAN MED AG
Open, ClassifiedFeb 28, 2025
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
Z-1251-2025 · View FDA record ↗

Registered firms

80 firms currently registered for this product code

510(k) clearances

58 clearances for this product code