Sana Device

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 16, 2026 Sana Health % John Doucet, PhD Vice President, Neurology Regulatory Affairs MCRA 803 7th St. NW Washington, District of Columbia 20001 Re: DEN250005 Trade/Device Name: Sana Device Regulation Number: 21 CFR 890.5775 Regulation Name: Audio-visual stimulator for pain relief Regulatory Class: Class I Product Code: QYN Dated: February 28, 2025 Received: March 3, 2025 Dear Dr. Doucet: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Sana Device, a prescription device under 21 CFR Part 801.109 with the following indications for use: The Sana Device is indicated for patients aged 18 and older as an adjunct to other modes of therapy for temporary relief of neuropathic pain for use at home or in the clinic. FDA concludes that this device should be classified into Class I. This order, therefore, classifies the Sana Device, and substantially equivalent devices of this generic type, into Class I under the generic name audio-visual stimulator for pain relief. FDA identifies this generic type of device as: **Audio-visual stimulator for pain relief.** An audio-visual stimulator for pain relief is a device intended to deliver light stimuli to the eyes and sound stimuli to the ears to provide pain relief. This device is intended to be used adjunctively to other modes of therapy to relieve pain. Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} DEN250005 - John Doucet, PhD Page 2 December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification. On March 3, 2025, FDA received your De Novo requesting classification of the Sana Device. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the Sana Device into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request, FDA has determined that, for the previously stated indications for use, the Sana Device can be classified in class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks to health are thermal injury or electrical shock, adverse tissue reaction, device failure due to interference with other devices, delayed or ineffective treatment due to use error, headache/migraine, light and/or sound sensitivity, pain, photosensitivity, nausea, insomnia, and anxiety. The Audio-Visual Stimulator for Pain Relief is subject to the general controls of the FD&C Act. Section 510(l) of the FD&C Act (21 U.S.C. 360(l)) provides that a class I device is not subject to the premarket notification requirements under section 510(k) of the FD&C Act unless the device is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. FDA has determined that the device does not meet these criteria and, therefore, premarket notification is not required for the device. Thus, persons who intend to market this device need not submit a premarket notification containing information on the audio-visual stimulator for pain relief they intend to market prior to marketing the device, subject to the limitations on exemptions in 21 CFR 890.9. In addition, this is a prescription device and must comply with 21 CFR 801.109. Although this letter refers to your product as a device, please be aware that some granted products may instead be combination products. If you have questions on whether your product is a combination product, contact CDRHProductJurisdiction@fda.hhs.gov. Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and if applicable, the electronic product radiation control provisions (Sections 531-542 of the FD&C Act; 21 CFR 1000-1050). {2} DEN250005 - John Doucet, PhD Page 3 All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System Rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday. As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order. For comprehensive regulatory information about medical devices and radiation-emitting products, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). If you have any questions concerning the contents of the letter, please contact Kaitlin Olsen at Kaitlin.Olsen@fda.hhs.gov. Sincerely, Heather L. Dean -S Heather Dean, PhD Acting Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health