Luminance RED Cold Sore Device
The Luminance RED Cold Sore Device delivers near-infrared light to herpes simplex lesions on and around the lips. It is intended to shorten healing time, defined by patient-reported…
The Luminance RED Cold Sore Device delivers near-infrared light to herpes simplex lesions on and around the lips. It is intended to shorten healing time, defined by patient-reported re-epithelialization of the lesion.
The handheld device uses LEDs to emit therapeutic light at 1072 nm, alongside a visible red guide light. The guide light helps position the treatment head and is separate from the near-infrared treatment output.
Controls and Users
The plastic body houses a lithium-ion battery, power and treatment buttons and a digital countdown timer. The device is intended for users with Fitzpatrick skin types I to IV.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Luminance Medical Ventures Incorporated, United States |
|---|---|
| FDA product code | OKJ |
| Device type | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K251973 |
| Record published | 2026-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TN1927G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Walgreens | Walgreen Co. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251973 | 2025-09-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.