(a) 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.

(b) 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.

[83 FR 52969, Oct. 19, 2018]