# K222205: Cold Sore Device (Model: QPZ-01)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Oct 7, 2022 after 74 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: 1 generation back to DEN090012 (2012). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090012: Virulite Cold Sore Machine, Virulite, LLC (2012) Summary page 4.
- DEN090012: Virulite Cold Sore Machine, Virulite, LLC (2012). Our reading of the summary gave K083767, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090012, Virulite Cold Sore Machine (Virulite, LLC), granted Oct 18, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.

## Most influential descendants
- K251973: Luminance Red Cold Sore Device (TN1927G) (2025), 0 descendants of its own
- K241155: Cold Sore Device (QPZ-03) (2024), 0 descendants of its own

## Indications for use
The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

Source page: https://510kreport.com/device/K222205
Methodology: https://510kreport.com/methodology