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OKJ

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Product code
OKJ
Device name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device class
Class 2
21 CFR
21 CFR 878.4860
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
4 (all years; only the last 3 years are listed here)

FDA classification definition

Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-23.

NumberDecision dateApplicantDevice nameSummary
K2519732025-09-23Luminance Medical Ventures, Inc.Luminance Red Cold Sore Device (TN1927G)FDA
K2411552024-09-05Shenzhen Nuon Medical Equipment Co., L…Cold Sore Device (QPZ-03)PDF

1 summaries are archived here for direct download.

Official FDA classification page: OKJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).