← FDA Medical Device Classifications

System, Suction, Lipoplasty For Removal

QPB · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.5040

Classification

FDA Product Code
QPB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.5040
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

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

Market data

Cleared 510(k) submissions
56
Registered establishments
48

Source

Authoritative
FDA Device Classification database
Machine
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