
Luminance RED Cold Sore Device
FDA-cleared red-light treatment device for cold sores on and around the lips
Inclusive of VAT
A small service fee is added at checkout.
- FDA-cleared Class II device
- Timed 60-second sessions
- Drug-free light treatment
- Compact, at-home design
Quantity:
TARGETED RED LIGHT
A focused routine for cold sores around the lips
The Luminance RED Cold Sore Device is designed for adults who want a drug-free, non-invasive treatment option they can use privately at home. Its angled light tip helps direct treatment toward the affected area without touching the skin.
- Targeted application
- No skin contact required
- Made for a repeatable routine

DEVICE DETAILS
Purpose-built for cold sores on and around the lips
FDA records identify model TN1927G as a Class II light-based treatment device for cold sores caused by herpes simplex virus-1. It is cleared for adult use. Follow the supplied instructions and seek medical advice when appropriate.
FDA 510(k) K251973
The FDA database lists the device as substantially equivalent under product code OKJ.
Automatic treatment timer
Each treatment cycle is programmed to stop automatically after 60 seconds.
Drug-free and non-invasive
The device uses directed light rather than a topical cream or oral medication.
Designed for adult home use
For anyone under 18, during pregnancy, or with specific medical concerns, consult a healthcare professional before use.


Simple hardware, clear treatment steps

Angled light tip
Helps aim the light toward sores on or around the lips.

Charging base
The product imagery shows a dedicated base for keeping the device ready between uses.

Private at-home use
The handheld format is designed for discreet personal use without a clinic visit.

Medical-device guidance
Use only as directed and review the supplied instructions, warnings and contraindications before starting.
HOW TO USE
A guided, timed treatment routine
Follow the manufacturer’s instructions supplied with your device. The steps below summarize the routine shown on the source product materials.
Identify the area
Use the device for a cold sore on or around the lips. Do not use it for a different condition or body area unless the instructions specifically allow it.
Position the tip
Hold the light tip approximately 1/2 inch (about 1 cm) from the affected area, without pressing it onto the skin.
Start the timed cycle
Press start and keep the light aimed at the area until the programmed 60-second cycle ends automatically.
Follow the recommended schedule
The manufacturer recommends up to three sessions per day, separated by about eight hours. Stop and seek advice if irritation or an unexpected reaction occurs.
PRODUCT FAQ
What to know before using the device
These answers summarize verified product and regulatory information. They are not a substitute for the instructions supplied with the device or professional medical advice.
What is this device intended for?
It is intended as a light-based treatment device for cold sores caused by herpes simplex virus-1 on and around the lips.
Is it FDA cleared?
Yes. FDA 510(k) K251973 lists the Luminance Red Cold Sore Device (TN1927G) as a Class II device with a substantially equivalent decision dated September 23, 2025.
How long is each session?
The programmed cycle lasts 60 seconds and stops automatically.
How often does the manufacturer recommend using it?
The source instructions recommend two to three sessions per day, spaced about eight hours apart. Always follow the instructions packaged with your exact device.
Can children use it?
The product is cleared for adults aged 18 and older. For anyone under 18, consult a healthcare professional before use.
What should I do if I am pregnant or taking medication?
Consult your healthcare professional before using a new medical device during pregnancy or when you have medication-related or condition-specific concerns.
Store ratings & reviews
No reviews yet
This seller has not received any reviews for their products yet. Be the first to share your experience.








