510(k) clearance

PicoreMax (PicoreMax)

FDA 510(k) source

510(k) number

K254199

Applicant

BLUECORE COMPANY Co., Ltd.

Decision date

Sep 24, 2026

Date received

Dec 29, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GEX

Device type

Powered Laser Surgical Instrument

Device class

Class II

Regulation

21 CFR 878.4810

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Yangsan, KR