21 CFR § 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.
---
identifier: "/us/cfr/t21/s878.4810"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4810"
section_name: "Laser surgical instrument for use in general and plastic surgery and in dermatology."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---
# 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) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]