# DEN090012: Virulite Cold Sore Machine

- Pathway: De Novo (Post-NSE)
- Applicant: Virulite, LLC
- Decided: Oct 18, 2012 after 1,206 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K222205: Cold Sore Device (Model: QPZ-01) (2022), 2 descendants of its own
- 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 ViruLite Cold Sore Machine 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/DEN090012
Methodology: https://510kreport.com/methodology