OKJ · Light Based Treatment For Cold Sores Herpes Simplex Virus-1
General, Plastic Surgery · 21 CFR 878.4860 · Class 2
Overview
| Product Code | OKJ |
|---|---|
| Device Name | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Regulation | 21 CFR 878.4860 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the light based energy source device for topical application is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized. (2) The cleaning and disinfection instructions for the device must be validated. (3) The device must be demonstrated to be biocompatible. (4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device. (5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device. (6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen. (7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance. (8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | Sep 23, 2025 | SESE |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | Sep 5, 2024 | SESE |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | Oct 7, 2022 | SESE |
| DEN090012 | VIRULITE COLD SORE MACHINE | Virulite, LLC | Oct 18, 2012 | DENG |
Top Applicants
- Light Tree Ventures Europe B.V. — 1 clearance
- Luminance Medical Ventures, Inc. — 1 clearance
- Shenzhen Nuon Medical Equipment Co., Ltd. — 1 clearance
- Virulite, LLC — 1 clearance
