510(k) clearance

Ellian Enigma RF Device

FDA 510(k) source

510(k) number

K262364

Applicant

Ellian Corp

Decision date

Sep 2, 2026

Date received

Jul 10, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GEI

Device type

Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class II

Regulation

21 CFR 878.4400

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Plano, TX, US