21 CFR § 874.4500
Ear, nose, and throat microsurgical carbon dioxide laser
June 25, 2020
(a) Identification. An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.
(b) Classification. Class II.