21 CFR §878.4810

1. (a)Identification.
   1. (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. (2)An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
2. (b)Classification.
   1. (1)Class II.
   2. (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.