510(k) K251973

Device

Luminance Red Cold Sore Device (TN1927G)

Applicant

Luminance Medical Ventures, Inc.

510(k) number

K251973

Product code

OKJ

Decision

Substantially Equivalent (SESE)

Decision date

2025-09-23

Date received

2025-06-26

Regulation

878.4860

Classification name

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Medical specialty

General, Plastic Surgery

Review panel

General, Plastic Surgery

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No