---
kind: "section"
citation: "21 C.F.R. § 878.4860"
title: "21"
number: "878.4860"
heading: "Light based energy source device for topical application."
url: "https://uscodex.org/cfr/21/878.4860"
---

# §878.4860. Light based energy source device for topical application.

- (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.

## Notes

### Amendments

[83 FR 52969, Oct. 19, 2018]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[83 FR 52969, Oct. 19, 2018]