21 CFR § 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.
§ 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.