---
kind: "section"
citation: "21 C.F.R. § 878.4810"
title: "21"
number: "878.4810"
heading: "Laser surgical instrument for use in general and plastic surgery and in dermatology."
url: "https://uscodex.org/cfr/21/878.4810"
---

# §878.4810. Laser surgical instrument for use in general and plastic surgery and in dermatology.

- (a) **Identification.**
  - (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.
  - (2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
- (b) **Classification.**
  - (1) **Class II.**
  - (2) **Class I for special laser gas mixtures used as a lasing medium for this class of lasers.** The devices subject to this [paragraph (b)(2)](#b-2) are exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 878.9](/cfr/21/878.9.md).

## Notes

### Amendments

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

### 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

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]