§ 878.4810. Laser surgical instrument for use in general and plastic surgery and in dermatology.
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/us/cfr/t21/s§ 878.4810·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]