(16 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components or algorithms. The operation is described as simple button presses controlling electrical pulses.
No
The device is described as being for "facial stimulation" and is "indicated for over-the-counter cosmetic use," rather than for treating or diagnosing any medical condition.
No
Explanation: The device is intended for "facial stimulation" and "cosmetic use" and does not mention any diagnostic capabilities or intended use in diagnosing disease or other conditions.
No
The device description explicitly details hardware components including a silicone mask, controllers with electrodes, a built-in Lithium-ion battery, a USB charging cable, and an adapter. The performance studies also mention testing related to biocompatibility and electrical components, indicating it is not solely software.
Based on the provided information, the Medi Lift Mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is explicitly stated as "facial stimulation and indicated for over-the-counter cosmetic use." This is a physical, non-diagnostic application.
- Device Description: The device description details a mask with electrodes that deliver electrical pulses to stimulate facial muscles. This is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The Medi Lift Mask's function is purely for physical stimulation for cosmetic purposes.
N/A
Intended Use / Indications for Use
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Product codes
NFO
Device Description
The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cheeks
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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
To evaluate the modification, the following activities were performed:
- . Risk analysis per ISO 14971:2019
- . Biocompatibility evaluation per ISO 10993-1:2018 and testing of:
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2021 o
- Intracutaneous reactivity per ISO 10993-23:2021 o
Since there were no changes to the silicone mask, software, electrodes, or other electrical components of the device, the risk analysis determined that the prior tests performed for the predicate device regarding tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility remained applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2025
YA-MAN Ltd % Lina Kontos Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004
Re: K244048
Trade/Device Name: Medi Lift Mask Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 31, 2024 Received: December 31, 2024
Dear Lina Kontos:
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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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory
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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, Tushar Bansal -S
for Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team 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
Enclosure
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Indications for Use
510(k) Number (if known) K244048
Device Name Medi Lift Mask
Indications for Use (Describe)
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K244048
YA-MAN Ltd.'s Medi Lift Mask
Submitter
YA-MAN Ltd. 2-4-2 Toyo, Koto-ku, Tokyo, 1350016 JAPAN Phone: +81-3-5665-7321 Facsimile: +81-5665-7370 Contact Person: Jun Takada
Date Prepared: December 31, 2024
Name of Device: Medi Lift Mask
Regulatory Classification: Class II, 21 CFR 882.5890
Product Code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
Predicate Device
510(k) Number: K220198 Trade Name: Medi Lift PLUS Manufacturer: YA-MAN Ltd. Product Code: NFO
Device Description
The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.
Intended Use/Indications for Use
The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Summary of Technological Characteristics
The Medi Lift Mask is a modification to the previously cleared Medi Lift PLUS (K220198). The devices have the same intended use and indications for use, and the technological characteristics
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of the Medi Lift Mask are nearly identical to that of the predicate device. The only difference is a change in the UV varnish material on the housing of the controllers.
The table below provides a comparison of the technological characteristics for the subject device and the predicate device.
| | Subject Device:
Medi Lift Mask | Predicate Device:
Medi Lift PLUS (K220198) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Product Code | NFO | NFO |
| Regulation Number | 21 CFR 882.5890 | 21 CFR 882.5890 |
| OTC or Prescription Use | OTC | OTC |
| Indications for Use | The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use. | The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use. |
| Intended Anatomical Position on the Face | Cheeks | Cheeks |
| Wearable or Handheld | Wearable | Wearable |
| Device Components | Silicone mask
Controllers with electrodes
Charging accessories (USB cable and AC adaptor) | Silicone mask
Controllers with electrodes
Charging accessories (USB cable and AC adaptor) |
| Number of Controllers (signal generators) | 2 | 2 |
| Number of Electrodes | 3 per controller | 3 per controller |
| Conductive Media | Water | Water |
| Power Source | Rechargeable 3.7 V Lithium-ion battery (1 per controller) | Rechargeable 3.7 V Lithium-ion battery (1 per controller) |
| Patient Leakage Current | Protection method: Type BF applied part | Protection method: Type BF applied part |
| Number of Output Modes | One treatment area / one mode | One treatment area / one mode |
| Number of Output Channels | 2 per controller | 2 per controller |
| Indicator Display | LED indicator lights | LED indicator lights |
| Timer Range | Fixed 10 minutes. The user cannot change the default setting. | Fixed 10 minutes. The user cannot change the default setting. |
| Weight | Controllers: 28 g each
Silicone mask: 120 g
Total: 176 g | Controllers: 28 g each
Silicone mask: 120 g
Total: 176 g |
| Dimensions [W x H x D] | Controllers: 90 x 55 x 20 mm each
Mask: 615 x 170 mm | Controllers: 90 x 55x 20 mm each
Mask: 615 x 170 mm |
| Electrode Area | $5.04 cm^2$ per electrode | $5.04 cm^2$ per electrode |
| Controller Housing Materials | ABS with a UV varnish | ABS with a UV varnish |
| Table 1: Comparison of Technological Characteristics | ||
|---|---|---|
| ------------------------------------------------------ | -- | -- |
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Performance Data
To evaluate the modification, the following activities were performed:
- . Risk analysis per ISO 14971:2019
- . Biocompatibility evaluation per ISO 10993-1:2018 and testing of:
- Cytotoxicity per ISO 10993-5:2009 o
- Sensitization per ISO 10993-10:2021 o
- Intracutaneous reactivity per ISO 10993-23:2021 o
Since there were no changes to the silicone mask, software, electrodes, or other electrical components of the device, the risk analysis determined that the prior tests performed for the predicate device regarding tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility remained applicable.
Conclusions
As shown above, the Medi Lift Mask has the same intended use and indications for use as the predicate device, the Medi Lift PLUS (K220198). The new UV varnish on the controller housing does not raise different types of safety and effectiveness questions, and risk analysis and biocompatibility testing shows that the Medi Lift Mask is as safe and effective as the predicate device. Thus, the Medi Lift Mask is substantially equivalent.