← Product Code OCO · K160477 # The Luco Hybrid OSA Appliance (K160477) _Luco Hybrid Osa Appliance, Inc. · OCO · Jul 29, 2016 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K160477 ## Device Facts - **Applicant:** Luco Hybrid Osa Appliance, Inc. - **Product Code:** OCO - **Decision Date:** Jul 29, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use 1. A device to be used for the treatment of sleep bruxism and 2. As an aid in the treatment of associated tension/migraine type headaches in adults. ## Device Story The Luco Hybrid OSA Appliance is an oral appliance designed for the treatment of sleep bruxism and associated tension/migraine headaches. It functions as a mechanical mouthguard worn by the patient during sleep. The device is prescribed by a clinician and used by the patient at home. It acts by providing a physical barrier or repositioning mechanism to mitigate the effects of bruxism, thereby reducing associated headache symptoms. The device is a non-invasive, patient-worn oral orthotic. ## Clinical Evidence No clinical data provided; substantial equivalence is based on device classification and intended use. ## Technological Characteristics The device is a mechanical oral appliance (mouthguard) classified under 21 CFR 872.5410. It is a non-powered, patient-worn dental orthotic. ## Regulatory Identification A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 29, 2016 Luco Hybrid OSA Appliance Inc. Dr. Ken Luco President 1419 Butternut Creek Road Kingston, K7L 4V3 Canada Re: K160477 Trade/Device Name: The Luco Hybrid OSA Appliance Regulation Number: 21 CFR 872.5410 Regulation Name: Mouthguard, Migraine/Tension Headache Regulatory Class: Class II Product Code: OCO, MQC Dated: June 28, 2016 Received: July 1, 2016 Dear Dr. Ken Luco: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Susan Runno, DDS, MA Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160477 Device Name The Luco Hybrid OSA Appliance ## Indications for Use (Describe) - 1. A device to be used for the treatment of sleep bruxism and - 2. As an aid in the treatment of associated tension/migraine type headaches in adults. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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