---
kind: "section"
citation: "21 C.F.R. § 878.4880"
title: "21"
number: "878.4880"
heading: "Phototherapy device for reducing the appearance of acute post-surgical incisions."
url: "https://uscodex.org/cfr/21/878.4880"
---

# §878.4880. Phototherapy device for reducing the appearance of acute post-surgical incisions.

- (a) **Identification.** This device consists of a light-emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include the following:
    - (i) Verification and validation testing of the spectrum and power intensity of the light source;
    - (ii) Heat dissipation from the area following device application; and
    - (iii) Biophotonic properties of the photoconverter gel, including radiant fluence (transmitted light and fluorescence) delivered through the photoconverter gel by the device.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance data must evaluate the sterility of the patient-contacting components of the device.
  - (4) Performance data must support the shelf life of the photoconverter gel by demonstrating continued sterility and functional performance over the identified shelf life.
  - (5) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device in the intended use environment.
  - (6) Software verification, validation, and hazard analysis must be performed for any software components.
  - (7) Labeling must include the following:
    - (i) A summary of the device technical specifications, including light wavelength, irradiance, and application area;
    - (ii) Warnings for ensuring eye safety, including use of protective eyeglasses used for both the operator and the patient; and
    - (iii) **A shelf life for the photoconverter gel.**

## Notes

### Amendments

[91 FR 23359, May 1, 2026]

### 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

[91 FR 23359, May 1, 2026]