DeviceClearance

Product code NEY— General, Plastic Surgery

Solero Microwave Tissue Ablation (MTA) System and Accessories

Classification name
System, Ablation, Microwave And Accessories
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
68
First cleared
Most recent

Market context for product code NEY

FDA has cleared 68 devices under product code NEY between 2001 and 2026, filed by 34 applicant companies. 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

last 15 years

Top applicants under product code NEY

Adverse events under product code NEY

product code NEY
Death
24
Injury
388
Malfunction
462
Other
1
Total
875

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 NEY

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