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WARNING LETTER

LEEL Tech MARCS-CMS 677297 —

Reference #:
CPT2300250
Product:
Medical Devices
Recipient:
Recipient Name
Xiong Li
Recipient Title
Owner
LEEL Tech

(b)(4)
Guangdong Sheng, 518000
China

Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS # 677297

August 7, 2024

Yan Gao - Attorney/Correspondent
IpSpeedygo@gmail.com

Refer to: CPT2300250

Dear Xiong Li and Yan Gao:

The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the CLYN (CZ001& CLYN Universal), LEEL, and SOLID (Solid CPAP & ONECLICK SOLID) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has reviewed the labeling for your devices on your website, http://leelpro.com (last visited June 4, 2024), and determined that the CLYN (CZ001& CLYN Universal); LEEL; and SOLID (Solid CPAP & ONECLICK SOLID are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered these devices into interstate commerce for commercial distribution without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed. On your firm’s website, your devices are described as using activated oxygen (ozone) to disinfect or sanitize Continuous Positive Airway Pressure (CPAP) therapy devices and CPAP accessories, and your website includes the following claims:

For the CLYN CPAP Cleaner-Model CZ001, your website makes the following claims:

  • “Safely controlled activated oxygen disinfection: The Clyn CPAP cleaning machine uses safe, activated oxygen to sanitize and disinfect your CPAP machine, mask and tubing thoroughly. Clyn kills bacteria, germs, and other pathogens safely and naturally with no water or harmful chemicals.”
  • “The ozone disinfection technology is widely used in the medical and water treatment industries.”
  • “The Clyn will start the sanitizing automatically, and the cleaning cycle includes 20 minutes of activated oxygen and 10 minutes of fresh air blowing.”

For the CLYN Universal CPAP BiPAP Cleaner and Sanitizer Kit, your website makes the following claims:

  • “Clyn CPAP sanitizer is designed to eliminate bacteria and germs found in CPAP and BIPAP machines and accessories, via the power of activated oxygen.”
  • “One-click CPAP sanitizing process: … Our Clyn O3N cleaner will process the sanitizing and automatically shut off when it's finished.”
  • “Simplify O3 Cleaning: safe-level activated oxygen sanitizing in 60 Minutes.”

For the LEEL CPAP Cleaner and Sanitizer Machine, your website makes the following claims:

  • “Safe and controlled activated oxygen disinfecting: LEEL CPAP cleaning device is proven activated oxygen kills 99% of germs, bacteria, and other pathogens. You can sanitize your CPAP machine, mask, and tubing entirely through a stream of controlled activated oxygen for approximately 20 or 30 minutes.”
  • “The LEEL O3 CPAP cleaner has optimized its sanitization cycle to 20/30 minutes. The 20 minutes cleaning cycle includes 15 minutes of activated oxygen sanitizing and 5 minutes of fresh air blowing; The 30-minute cleaning cycle includes 20 minutes of activated oxygen sanitizing and 10 minutes of fresh air blowing.”

For the LEEL CPAP Cleaner with Heated Hose Adapter Set, your website makes the following claims:

  • “LEEL CPAP cleaner kills germs via the power of activated oxygen (ozone). The ozone could reach every corner of your CPAP device and accessories, killing 99% of germs and bacteria! No water, no chemicals, and fast cleaning.”
  • “LEEL CPAP cleaning device helps reduce the unpleasant smell from the mask, tubing, and water reservoir. The 2-speed fans will blow fresh air through in the last 10 minutes of the cleaning cycle.”
  • “No water cleaning solution; Count down timer; Sanitize in 20/30 minutes.”

For the One-Click Ozone CPAP Cleaner and Sanitizer Bundle |SolidCLEANER, your website makes the following claims:

  • “You can use SolidCLEANER for an easy way of sanitizing your CPAP equipment and accessories when you are tired of cleaning your CPAP mask and hose manually.”
  • “Ultra-Clean: Solidcleaner is built in an ozone generator that produces ozone to kill 99.9% of the germs and pathogens in your CPAP hose, mask, and sleep equipment machine & reservoir. Say goodbye to messy liquids and chemicals. Fast and new CPAP cleaning method.”
  • “The SolidCLEANER has optimized its sanitizing cycle to 20 or 30 minutes which generates enough time for activated oxygen sanitizing and fresh air blowing in to reduce the ozone odor left in the last stage.”

For Solid CPAP Cleaner and Sanitizer Machine | Model CC01, your website makes the following claims:

  • “Most effective and easy CPAP cleaning solution.”

On May 10, 2023, the FDA sent a letter to your firm, LEEL Tech, stating that the LEEL, CLYN (CZ001& CLYN Universal), and SOLID (Solid CPAP & ONECLICK SOLID) CPAP Cleaners appear to meet the definition of a device under the FD&C Act and that they do not appear to be Class I exempt medical devices. In email responses on August 15, 2023, and November 27, 2023, you stated that LEEL Tech is an “agent for CPAP cleaner machines,” does not directly produce or manufacture the devices, and that you planned to continue selling your remaining inventory of the devices.

Your response is inadequate because it does not address the lack of clearance or approval for the devices. Based on your response, you are responsible for initially importing these CPAP cleaning products into the United States and further distributing them to customers in the United States. These actions are prohibited acts under section 301 of the FD&C Act, 21 U.S.C. § 331, because, as noted above, these devices are adulterated and misbranded due to lack off approval or clearance.

Our office requests that LEEL cease any activities that result in the misbranding or adulteration of the CLYN (CZ001& CLYN Universal), LEEL, and SOLID (Solid CPAP & ONECLICK SOLID), such as the commercial distribution of the devices for the uses discussed above.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the identification number CPT2300250 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Dr. Bifeng Qian at bifeng.qian@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.

Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, FACS
Director
OHT4: Office of Surgical and Infection Control
Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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