{"data":{"id":"us/21-cfr-884.4550","jurisdiction":"us","citation":"21 CFR 884.4550","heading":"Gynecologic surgical laser.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart E—Obstetrical and Gynecological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"86ea08310477c5414a422088143b33e81bf81bc1c229b964e54e40feea1e811c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.4530","next":"us/21-cfr-884.4900"},"notice":"GroundRules: Original legal text. Not legal advice."}