Lipoaspirate Washing System For Aesthetic Body Contouring

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

Classification

FDA Product Code: QKL
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

Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation

Market data

Cleared 510(k) submissions: 0
Registered establishments: 27

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown