Gynecologic surgical laser.

21 C.F.R. § 884.4550
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
(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).

Starting a business? Corpus forms LLCs in all 50 states and DC.