Who is the manufacturer of Medi Lift PLUS?

Ya-Man, Ltd. filed the 510(k) submission for Medi Lift PLUS (K220198).

What is the FDA product code for Medi Lift PLUS?

NFO. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Medi Lift PLUS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medi Lift PLUS?

Ageless Wonder Facial Muscle Stimulation System (K120511).

Who can help prepare an FDA 510(k) submission like Medi Lift PLUS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medi Lift PLUS

K220198 · Ya-Man, Ltd. · NFO · Jun 28, 2023 · Neurology

Device Facts

Record ID	K220198
Device Name	Medi Lift PLUS
Applicant	Ya-Man, Ltd.
Product Code	NFO · Neurology
Decision Date	Jun 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.

Device Story

Medi Lift PLUS is a wearable silicone mask covering the lower face (cheeks and nose) for cosmetic facial muscle stimulation. The device consists of a silicone mask with two integrated controllers and electrodes. The user moistens the cheeks with tap water to facilitate conductivity, wears the mask, and operates the controllers via buttons to adjust electrical pulse intensity. The device delivers symmetric pulsed biphasic and quadphasic electrical pulses to facial muscles. It is intended for home use by the consumer. The device is powered by a rechargeable Lithium-ion battery. The output is fixed at a 10-minute treatment duration. The device provides non-invasive electrical stimulation to the facial muscles, intended for cosmetic toning purposes.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical output verification, biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-18), mechanical tensile strength, and software verification/validation. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10 was demonstrated.

Technological Characteristics

Wearable silicone mask with two ABS controllers. Energy source: 3.7V Lithium-ion battery. Output: Symmetric pulsed biphasic and quadphasic waveforms; rectangular pulses. Max output voltage: 39.3 Vpp @500Ω. Max output current: 3.22 mA @500Ω. Connectivity: USB charging. Applied part: Type BF. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, ISO 10993-18.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation in adults.

Regulatory Classification

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.

Predicate Devices

Ageless Wonder Facial Muscle Stimulation System (K120511)

Reference Devices

BMR face (K103031)

Related Devices

K244048 — Medi Lift Mask · Ya-Man, Ltd. · Jan 16, 2025
K250618 — Medi Lift Essential Eye Mask · Ya-Man, Ltd. · Oct 29, 2025
K120511 — AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM · Leto Enterprise , Ltd. · Jul 30, 2012
K221443 — PureLift Pro Plus · Xtreem Pulse, LLC · Oct 21, 2022
K190269 — PureLift · Xtreem Pulse, LLC · Aug 28, 2019

Submission Summary (Full Text)

{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. June 28, 2023 YA-MAN Ltd % Jonathan Kahan Regulatory Counsel Hogan Lovells US LPP 555 Thirteenth Street NW Washington, District of Columbia 20004 Re: K220198 Trade/Device Name: Medi Lift PLUS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: June 26, 2023 Received: June 26, 2023 Dear Jonathan Kahan: 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. 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 located 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. 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 {1}------------------------------------------------ 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 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-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/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-regulatoryassistance/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, Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and stands out against a white background. The letters are evenly spaced, and the overall impression is clean and legible. The image appears to be a cropped section of a larger document or presentation. for Heather Dean, PhD 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220198 Device Name Medi Lift PLUS Indications for Use (Describe) The Medi Lift PLUS 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) #### 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." {3}------------------------------------------------ #### 510(k) SUMMARY #### YA-MAN Ltd's Medi Lift PLUS #### Submitter YA-MAN 2-4-2 Toyo, Koto-ku, Tokyo, 1350016 JAPAN Phone: +81-3-5665-7321 Facsimile: +81-5665-7370 Contact Person: Jun Takada Date Prepared: June 28, 2023 Name of Device: Medi Lift PLUS Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Regulatory Class: Class II Product Code: NFO #### Predicate Device 510(k) Number: K120511 Trade Name: Ageless Wonder Facial Muscle Stimulation System Manufacturer: Leto Enterprise Ltd Product Code: NFO #### Reference Device 510(k) Number: K103031 Trade Name: BMR face Manufacturer: Bio-Medical Research, Ltd. Product Code: NFO #### Device Description The Medi Lift PLUS is composed of a mask made of silcone 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 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. The device is not operated during charging. {4}------------------------------------------------ ## Intended Use / Indications for Use The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use. ## Summary of Technological Characteristics The intended use of the Medi Lift PLUS is identical to that of the predicate device, namely both devices are indicated for over the counter facial stimulation, and use the same technology of energy delivered through electrodes placed on the user's face. The output waveform of the Medi Lift PLUS is Symmetric Pulsed biphasic and quadphasic, and the maximum output voltage of the Medi Lift PLUS is in the range of the that of the predicate device. The maximum output current of the Medi Lift PLUS is higher than the predicate device, but that is lower than the reference device. The differences regarding main output specifications between Medi Lift PLUS device and the predicate or reference devices do not raise new or different questions of safety and effectiveness. A table comparing the key features of the subject and predicate devices is provided below. | Characteristics | Medi Lift PLUS | Predicate Device Ageless Wonder (K120511) | Reference Device BMR face (K103031) | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code | NFO | NFO | NFO | | Regulation Number | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | | OTC or Prescriptive use | OTC | OTC | OTC | | Intended use | The Medi Lift PLUS is intended for facial stimulation and indicated for over-the- counter cosmetic use. | Ageless Wonder Facial Toning Device is intended for facial stimulation and indicated for over-the- counter cosmetic use. | BMR Face. Type 371/372, is a facial toning product which delivers electrical stimulation to the face for cosmetic use. | | Intended anatomical position in the face | Cheeks | Cheeks (headset) /Forehead, Chin and jawline, under eye area (handheld) | Cheeks | | Wearable or handheld | Wearable | Wearable and Handheld | Wearable | | Operation of the device | A user attaches two controllers to the right and left sides of the silicone mask so that the silicone mask holds the controllers. The user moistens cheeks with tap water and then wears the | A user attaches the conductive sponges onto the two application wands and wets the sponges. The wands are applied to the headset. The user fits the headset to the face. The wands with | A user attaches the gel pads to the two paddles of the headset and fits the headset to the face. The paddles with gel pads deliver electrical impulses from the controller to the face. The headset | | Characteristics | Medi Lift PLUS | Predicate Device Ageless Wonder (K120511) | Reference Device BMR face (K103031) | | | silicone mask which covers lower part of the user's face. The silicone mask is adjusted to positions of user's eyes, nose, and mouth. The user fixes the mask with a hook and loop fastener in the distal parts of the mask. The controllers have electrodes which deliver electrical impulses to the cheeks. Also, the controllers have +/ON button for turning on the device and increasing intensity and -/OFF button for turning off the device and decreasing intensity. The user operates the device using the controllers. | wet sponges deliver electrical impulses from the controller to the face. The headset is connected to the control unit which has ON/OFF button, increase or decrease intensity on both wands of the headset, mode button, and display. The user operates the device using the control unit. The user can hold the wands with the hands and place and operate the device on the forehead, the chin and jawline, and under eye area. | is connected with the control unit which has ON/OFF/pause button, increase or decrease intensity on the left and right sides of the headset, information button, program button and display. The user operates the device using the control unit. | | Number of Controller (signal generator) | 2 | 1 | 1 | | Conductive Media | Water | Water | N/A because the reference device contains gel pads. | | Power source | One 3.7 V Lithium ion battery/one signal generator | Two of 1.5 V AAA battery | 3.6V NiMH rechargeable battery pack | | Patient Leakage Current | Protection method: Type BF applied part | Protection method: Type BF applied part | Not applicable, no line connection, no AC charger connection or operation. Connection method does not allow AC charger connection. Normal condition: 0µA Single fault condition: 0µA | | Number of Output Modes | One treatment area / one mode | One treatment area/ one mode x 6 treatment areas | One treatment area/ Three treatment modes | | Number of Output Channels | 2/ one controller | 1 | 2 | | Characteristics | Medi Lift PLUS | Predicate Device Ageless Wonder (K120511) | Reference Device BMR face (K103031) | | Timer Range (minutes) | Fixed 10 minutes. The user cannot change the default setting. | 5 – 20 minutes. The user can select the treatment time form 5, 10, 15, or 20 minutes. | 20 minutes for program 1, 10 minutes for program 2, 20 minutes for program 3/ The user cannot change the default setting. | | Compliance with Voluntary Standards | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 ISO 10993-5 ISO 10993-10 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-10 ISO 10993-5 ISO 10993-10 | IEC60601-1 IEC 60601-2-10 IEC 60601-1-2 Battery charger IEC60950 and UL1950 | | Weight | 28 g / one controller, Silicone mask 120 g: Total 176 g | 90 g (including a headset) | 63 g | | Dimensions [W x H x D] | Controller 90 x 55x 20 (mm) Mask 615 x 170 (mm) | 98.5x 53 x 27.5 (mm) | 6.0 x 8.0 x 2.1 (cm) | | Housing Materials and Construction | ABS | Unknown | ABS | Table 7-1: Comparison Table For Basic Technological Characteristics {5}------------------------------------------------ {6}------------------------------------------------ The following Table 7-2 shows the comparison between the output specification of the Medi Lift PLUS, the predicate and the reference devices. | Specification | Medi Lift PLUS | Predicate Device Ageless Wonder (K120511) | Reference Device BMR Face (K103031) | |----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------| | Waveform | Symmetric Pulsed Biphasic and Quadphasic | Unknown | Pulsed, symmetric, biphasic | | Shape | Rectangular pulses | Unknown | Rectangular, with interphase interval | | Maximum Output Voltage | 39.3 Vpp @500Ω (+/- 20%) | 0 to 51V (0- 1000Ω) | Output-Peak voltage 15.1 V@500Ω 60.6V @2kΩ 30.3 V@10KΩ (+/- 10%) | | Maximum Output Current | 3.22 mA@500Ω (+/- 20%) | 0 to 43.2μA (0 to1000Ω) | Output-Peak current 30.2 mA@500Ω 30.3 mA@2kΩ 3.0 mA@10kΩ (+/- 10%) | | Specification | Medi Lift PLUS | Predicate Device Ageless Wonder (K120511) | Reference Device BMR Face (K103031) | | Pulse Width | 152/168/192 µs ±10% (@2.5-100Hz), 52µs ±10%(@ 1kHz) | 150 µs | 300 µS max (both phase + 100 µS interphase delay) | | Frequency (Hz) | 2.5Hz, 5 Hz, 6Hz, 7Hz, 8Hz, 9Hz, 10 Hz, 20 Hz, 25 Hz, 33 Hz, 50 Hz, 66 Hz, 100Hz, 1 k Hz | Unknown | 70Hz, 80Hz | | For interferential modes only: - Beat Frequency (Hz) | NA | NA | NA | | For multiphasic waveforms only: - Symmetrical phases? | Yes | Unknown | Yes | | - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | 38/42/48 µs ±10% (@2.5-100Hz), 26µs ±10%(@ 1kHz) | Unknown | 80-100μS symmetrical | | Net Charge (mC per pulse) | 0 | Unknown | 0@500Ω Symmetric, biphasic and leading polarity alternates for each successive pulse | | Maximum Phase Charge, (mC) | 0.084µC@500Ω | Unknown | 3.0 µC@500Ω | | Maximum Current Density, (mA/cm²) | 0.64 mA/cm²@500Ω =3.22 mA@1kHz / 5.04 cm² (area of a electrode. All 6 electrode of the device are the same size) | Unknown | 0.4 mA/cm²@ 500Ω | | Maximum Power Density, (W/cm²) The maximum power density should be less than 0.25 Watts/cm2 to reduce the risk of thermal burns. | I²×R = (0.00322)²×500 =0.0052 Watts = 5.2 mW 0.0052 /5.04 = 0.0010 W/ cm² | Unknown | 0.34mW/cm²@ 500Ω | | ON Time (seconds) | 0.2 to 16 seconds (Depending on the pattern of output and the intensity level) | Unknown | Unknown | | OFF Time (seconds) | 1 to 4 seconds (Depending on the pattern of output) | Unknown | Unknown | ## Table 7-2 Comparison of The Output Specification {7}------------------------------------------------ {8}------------------------------------------------ ## Performance Data The Medi Lift PLUS device was assessed in accordance with the following standards: - . IEC60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests. - . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - . Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). - . IEC 60601-1-11: 2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. - IEC 60601-2-10:2012, AMD1:2016, Medical electrical equipment Part 2-10: Particular ● requirements for the basic safety and essential performance of nerve and muscle stimulators. - ISO10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity. - ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization. - · Chemical characterization with targeted analysis for polycyclic aromatic hydrocarbons, according to ISO 10993-18:2020 - Tensile strength of the mask - · Electrical output of the Medi Lift PLUS - Software verification and validation ## Conclusions The Medi Lift PLUS is as safe and effective as the predicate device. The Medi Lift PLUS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the Medi Lift PLUS and its predicate device raise no new issues of safety or effectiveness. Thus, the Medi Lift PLUS is substantially equivalent to the predicate device.