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e-CFR data is current as of September 18, 2020

Title 21Chapter ISubchapter HPart 884Subpart E → §884.4550


Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart E—Obstetrical and Gynecological Surgical Devices


§884.4550   Gynecologic surgical laser.

(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).

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