{"abstract":"The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled \"Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.\" The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2004/12/28/04-28251.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"69 FR 77623","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective January 27, 2005. The classification was effective November 4, 2004.","disposition_notes":null,"docket_ids":["Docket No. 2004N-0530"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-05-12T11:55:54.091-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-N-0497-0001","allow_late_comments":false,"id":"FDA-2004-N-0497-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2004-N-0497","title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System"}],"document_number":"04-28251","effective_on":"2005-01-27","end_page":77624,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/12/28/04-28251.xml","html_url":"https://www.federalregister.gov/documents/2004/12/28/04-28251/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-assisted-reproduction","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-28251?publication_date=2004-12-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-12-28/04-28251/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":39,"last_updated":"2026-10-24 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-12-28/pdf/04-28251.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-12-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/12/28/04-28251.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2004-N-0497","supporting_documents_count":0,"docket_id":"FDA-2004-N-0497","document_id":"FDA-2004-N-0497-0001","regulation_id_number":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System","checked_regulationsdotgov_at":"2025-05-13T18:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":77623,"subtype":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System","toc_doc":"Assisted reproduction laser system; classification","toc_subject":"Medical devices:","topics":["Medical devices"],"type":"Rule","volume":69}