DeviceClearance

Product code QGM— General, Plastic Surgery

Edison System

Classification name
Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Device class
Class 2
Regulation
21 CFR 878.4405
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification definition

“This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.”

— U.S. Food and Drug Administration, device classification record for product code QGM under 21 CFR 878.4405, via openFDA

Market context for product code QGM

FDA has cleared 3 devices under product code QGM between 2023 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QGM

Adverse events under product code QGM

product code QGM
Death
9
Total
9

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QGM

Data sourced from openFDA. This site is unofficial and independent of the FDA.