DeviceClearance

Product code GEI— General, Plastic Surgery

InMode RF System

Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
2,316
First cleared
Most recent

FDA classification definition

“Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code GEI under 21 CFR 878.4400, via openFDA

Market context for product code GEI

FDA has cleared 2,316 devices under product code GEI between 1976 and 2026, filed by 754 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 GEI

Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

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 GEI

1–100 of 2,316

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