21 CFR § 884.4550 Obstetrical and Gynecological Devices

§ 884.4550 Gynecologic surgical laser.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.4530 Obstetric-gynecologic specialized manual instrument.§ 884.4900 Obstetric table and accessories. →