(78 days)
Not Found
No
Reasoning: The device description focuses on mechanical repositioning of the jaw and does not mention any electronic components, data processing, or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is intended to reduce snoring, which is typically considered a symptom or nuisance, not a disease or condition that requires therapy. Therapeutic devices treat, mitigate, or cure a disease or condition.
No
The device is described as an anti-snoring device that repositions the jaw to reduce snoring, not to diagnose a condition. The "Intended Use" states it is "intended to help reduce snoring."
No
The device description indicates it is a physical device that repositions the lower jaw, which is a mechanical intervention, not a software function. The performance studies also refer to physical properties and biocompatibility, further confirming it is a physical hardware device.
No
An IVD is a device used in vitro to examine specimens derived from the human body to provide information for diagnostic, monitoring or screening purposes. This device is an oral appliance used to reduce snoring, not for in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
Product codes
LRK, LQZ
Device Description
The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility test: Bio-compatibility assessment was conducted in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Physical properties: The materials used for the device have passed the following performance tests: flexural strength and flexural modulus, tensile strength and elongation at break, water absorption, melting temperature, and density.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Doc ID # 04017.07.04
Silver Spring, MD 20993
www.fda.gov
May 8, 2025
Fissiontech LLC
℅ Chang Libray
Manager
Shanghai Spica Management Consulting Co., Ltd.
609 Room, No.133 Shengang Avenue, Pudong New District
Shanghai, 200120
CHINA
Re: K250482
Trade/Device Name: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
Regulation Number: 21 CFR 872.5570
Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea
Regulatory Class: Class II
Product Code: LRK, LQZ
Dated: December 5, 2024
Received: February 19, 2025
Dear Chang Libray:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K250482 - Chang Libray Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, 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-
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K250482 - Chang Libray Page 3
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).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250482
Device Name: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
Indications for Use (Describe):
The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
Type of Use (Select one or both, as applicable):
- ☐ Prescription Use (Part 21 CFR 801 Subpart D)
- ☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary-K250482
Type of submission: Traditional
Date prepared: May 7, 2025
Submission sponsor
Manufacturer Name: FISSIONTECH LLC
Address: 1 LIBERTY STREET,FLOOR 3, NEW YORK CITY NEW YORK 10006
Tel: 314 475 4711
Email: mike@everymarket.com
Contact Person: Mike Lee
Device identification
Trade Name: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
Regulation Number: 21 CFR 872.5570
Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea
Device Classification: Class II
Product Code: LRK
Panel: Dental
Application correspondent
Company Name: Shanghai Spica Management Consulting Co., Ltd.
Address: 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China
Tel: 86-13020102321
Email: Libray@spicagloble.com
Contact Person: Libray Chang
Predicate device information
Sponsor: FISSIONTECH LLC
Trade/Device Name: Difiney Anti Snoring Device
510(K) number: K233850
Regulation Number: 21 CFR 872.5570
Indications for use
The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.
Device description
The Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring. The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
Page 6
Page 2 of 5
Technological Characteristic
Provided below is a comparison of the subject device with the predicate device.
Table 4A: General Comparison
| Item | Subject Device(K250482) | Predicate Device (K233850) | Comparison |
|---|---|---|---|
| Product Code | LRK | LRK | Same |
| Class | Class II | Class II | Same |
| Classification Name | Anti-Snoring Device | Anti-Snoring Device | Same |
| Proprietary Name | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Difiney Anti Snoring Device | / |
| Technological Features | Advanced Anti Snoring Device 4.0 helps reduce snoring by moving the lower jaw forward to open your airway to improve breathing allowing air to flow freely without the unhealthy and annoying sound of snoring. | Difiney Anti Snoring Device helps reduce snoring by moving the lower jaw forward to open your airway to improve breathing allowing air to flow freely without the unhealthy and annoying sound of snoring. | Same |
| Intended Use | The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older. | The Difiney Anti Snoring device is intended to help reduce snoring in adults 18 years of age or older. | Same |
| Materials | - Polycarbonate resin | - Polycarbonate resin | Same |
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Page 3 of 5
| Item | Subject Device(K250482) | Predicate Device (K233850) | Comparison |
|---|---|---|---|
| Materials (cont.) | - Ethylene vinyl acetate copolymer | - Ethylene vinyl acetate copolymer | |
| Desirable Characteristics | Home use, heat sensitive / moldable, adjustable jaw advancement position | Home use, heat sensitive / moldable, adjustable jaw advancement position | Same |
| Specifications: - Physical: - Mechanical: - Single use: | - Custom-fitted intraoral device - Repositions mandible anteriorly - Reusable | - Custom-fitted intraoral device - Repositions mandible anteriorly - Reusable | Similar |
| Mandibular advancement range | Repositions mandible anteriorly up to 6 mm at 1mm increment | Repositions mandible anteriorly up to 4 mm at 1mm increment | Different 1 |
| Design | Small anterior protrusion present | No anterior protrusion | Different 2 |
| Manufacturing Process | Injection molding | Injection molding | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
Different 1
The difference between a maximum advancement of 6 mm versus 4 mm is that 6 mm provides a greater degree of airway expansion, which can more effectively reduce snoring. Both devices advance in 1 mm increments, the difference is that the subject device provides 2 mm greater advancement than the predicate device; no other design features have been changed. Therefore, this difference does not impact the safety or effectiveness of the product.
Different 2
The small protrusion on the predicate device may cause discomfort for the user. In the subject device, we have removed this protrusion to improve wearing comfort. This is purely a design difference and does not affect the device's safety or effectiveness.
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Page 4 of 5
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility test
Bio-compatibility assessment was conducted in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Physical properties
The materials used for the device have passed the following performance tests: flexural strength and flexural modulus, tensile strength and elongation at break, water absorption, melting temperature, and density.
Page 9
Page 5 of 5
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue is substantially equivalent to the legally marketed predicated device K233850.