510(k) clearance

Scarlet Pro (Scarlet Pro)

FDA 510(k) source

510(k) number

K253859

Applicant

VIOL Co., Ltd.

Decision date

Aug 27, 2026

Date received

Dec 3, 2025

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

Gyeonggi-Do, KR