Product code OAB

Device name

Low Energy Direct Current Thermal Ablation System

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4400

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Ablation of soft tissue

Source

FDA openFDA device classification dataset