{"abstract":"The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the 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/2011/08/19/2011-21195.html","cfr_references":[{"chapter":null,"citation_url":null,"part":886,"title":21}],"citation":"76 FR 51876","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 19, 2011. The classification was effective on June 28, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-M-0570"],"dockets":[],"document_number":"2011-21195","effective_on":"2011-09-19","end_page":51878,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/08/19/2011-21195.xml","html_url":"https://www.federalregister.gov/documents/2011/08/19/2011-21195/medical-devices-ophthalmic-devices-classification-of-the-eyelid-thermal-pulsation-system","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-21195?publication_date=2011-08-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-08-19/2011-21195/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":203,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-08-19/pdf/2011-21195.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-08-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/08/19/2011-21195.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-08T08:05:57Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51876,"subtype":null,"title":"Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System","toc_doc":"Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":76}