21 C.F.R. § 884.4550
Gynecologic surgical laser.
Cite as 21 C.F.R. § 884.4550 (2026)
(a)
Identification.
A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.
(b)
Classification.
Class II (performance standards).