# K251973: Luminance Red Cold Sore Device (TN1927G)

- Pathway: 510(k) (Traditional)
- Applicant: Luminance Medical Ventures, Inc.
- Decided: Sep 23, 2025 after 89 days
- Product code: OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1)
- Device class: 2
- Regulation: 21 CFR 878.4860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN090012 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222205: Cold Sore Device (Model: QPZ-01), Light Tree Ventures Europe B.V. (2022) Summary page 5.

## Indications for use
The Luminance Red Cold Sore device is indicated for shortening the time to healing of herpes simplex labialis lesions on and around the lips with time to healing defined as the time to patient described re-epithelialization. This device is suitable for users with Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K251973
Methodology: https://510kreport.com/methodology