---
kind: "section"
citation: "21 C.F.R. § 878.4420"
title: "21"
number: "878.4420"
heading: "Electrosurgical device for over-the-counter aesthetic use."
url: "https://uscodex.org/cfr/21/878.4420"
---

# §878.4420. Electrosurgical device for over-the-counter aesthetic use.

- (a) **Identification.** An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
  - (2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
  - (3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
  - (4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
  - (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (6) Instructions for cleaning the device must be validated.
  - (7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
  - (8) Software verification, validation, and hazard analysis must be performed.
  - (9) Labeling must include:
    - (i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
    - (ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
    - (iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.

## Notes

### Amendments

[81 FR 42244, June 29, 2016]

### 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

[81 FR 42244, June 29, 2016]