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

21 C.F.R. § 878.4810
in effectEffective: 2024-07-01
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(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.

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