(520 days)
No
The device description and performance studies focus on electrical stimulation and standard safety/performance testing, with no mention of AI/ML or related concepts like data sets or algorithms.
No
The device's intended use is explicitly stated as "facial stimulation and indicated for over-the-counter cosmetic use," not for treating or diagnosing any medical condition.
No
The intended use of the Medi Lift PLUS is for "facial stimulation and indicated for over-the-counter cosmetic use," which describes a therapeutic or cosmetic purpose, not a diagnostic one. The device description also focuses on delivering electrical pulses to stimulate muscles, not on detecting, monitoring, or diagnosing medical conditions.
No
The device description explicitly details hardware components including a silicone rubber mask, controllers with electrodes, charging pins, a Lithium-ion battery, a USB charging cable, and an adapter. The performance studies also include testing related to electrical output and tensile strength of the mask, further indicating a hardware component. While software verification and validation are mentioned, this is for the software controlling the hardware, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial stimulation and indicated for over-the-counter cosmetic use." This describes a physical interaction with the body for cosmetic purposes, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device delivers electrical pulses to stimulate facial muscles. This is a physical therapy or cosmetic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts directly with the user's face.
- Performance Studies: The performance studies focus on electrical safety, biocompatibility, and physical properties of the device, which are typical for medical devices that interact with the body, but not specifically for IVDs.
- Predicate Devices: The predicate devices listed (Ageless Wonder Facial Muscle Stimulation System and BMR face) are also facial stimulation devices, not IVDs.
In summary, the Medi Lift PLUS is a device for external facial stimulation for cosmetic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Product codes
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.
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
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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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,
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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)
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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.