OKJClass II
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
General, Plastic Surgery · 21 CFR 878.4860
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances4All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Luminance Medical Ventures, Inc.Sep 23, 2025
K251973 · Luminance Red Cold Sore Device (TN1927G)
- Shenzhen Nuon Medical Equipment Co., Ltd.Sep 5, 2024
K241155 · Cold Sore Device (QPZ-03)
- Light Tree Ventures Europe B.V.Oct 7, 2022
K222205 · Cold Sore Device (Model: QPZ-01)
- Virulite, LLCOct 18, 2012
DEN090012 · VIRULITE COLD SORE MACHINE