21 C.F.R. § 884.4550

Gynecologic surgical laser.

Last amended: 2016Year: 2026Length: 63 wordsSubsections: 2Official source

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).
21 C.F.R. § 884.4550: Gynecologic surgical laser. | Justis AI