(102 days)
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
The provided FDA 510(k) clearance letter and summary for the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not contain information about acceptance criteria for performance related to its cosmetic claims, nor does it detail a study that proves the device meets such criteria.
The document confirms that clinical performance data and animal studies were not required for this submission. The assessments conducted were primarily for safety and electrical characteristics to ensure the device is as safe and effective as its predicate devices, rather than measuring the cosmetic effect of the device itself.
Therefore, the following information, based on the provided text, will reflect the absence of specific acceptance criteria or studies related to cosmetic performance, and will focus on the safety and technical compliance criteria.
Acceptance Criteria and Study Proving Device Meets Criteria for SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1
The provided FDA 510(k) submission primarily focuses on establishing the substantial equivalence of the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 to predicate devices concerning safety and technical characteristics. The document does not specify acceptance criteria related to its cosmetic effects (e.g., face-lift efficacy) or include a clinical study designed to demonstrate performance against such cosmetic criteria.
The acceptance criteria mentioned are related to electrical and mechanical safety, electromagnetic compatibility, software validation, and biocompatibility, ensuring the device is safe for its intended use as an over-the-counter stimulation device for cosmetic use.
1. A table of acceptance criteria and the reported device performance
Since specific performance acceptance criteria for cosmetic "face-lift" efficacy are not detailed in the provided document, the table below focuses on the reported technical performance and compliance with relevant safety standards. The "Acceptance Criteria" are implied by the standards the device claims compliance with and the comparisons to predicate devices.
| Acceptance Criteria (Implied by Compliance Standards & Predicate Comparison) | Reported Device Performance |
|---|---|
| Electrical Safety & Basic Performance (IEC 60601-1) | Compliant. Bench testing and third-party accredited laboratory evaluation confirmed waveform and output energy characteristics meet intended specifications and national/international standards. |
| EMC (IEC 60601-1-2) | Compliant. Device tested and demonstrated compliance. |
| Home Use Medical Devices (IEC 60601-1-11) | Compliant. Device tested and demonstrated compliance. |
| Nerve & Muscle Stimulators (IEC 60601-2-10) | Compliant. Third-party accredited laboratory evaluated the device in accordance with this standard. Output current, voltage, and current density are within established safety limits and compared favorably to predicate devices. Max output current (760μA@500Ω) and Max current density (0.56mA/cm² @ 500Ω) are significantly lower than standard limits (50mA and 2 mA/cm² respectively). |
| Biocompatibility (ISO 10993-1, -5, -10, -12, -23) | Compliant. Biocompatibility evaluation performed for patient-contacting components (housing materials, spheres), showing no adverse skin reactions. |
| Ingress Protection (IEC 60529) | Compliant. Device tested and demonstrated compliance. |
| Usability Engineering (IEC 62366) | Compliant. Device tested and demonstrated compliance. Feedback mechanisms (tactile and sound) address lack of visual indicator. |
| Risk Management (ISO 14971) | Compliant. Device tested and demonstrated compliance. Substantial reduction in maximum power density compared to some predicates minimizes thermal/electrical injury risk. |
| Software Verification & Validation | All testing conducted as recommended by FDA guidance. Software classified as "basic" level of concern. |
| Maximum Output Voltage | 25.2VDC (No Load). Lower than some predicates (28VDC), considered safe. |
| Maximum Output Current | 760μA@500Ω. Falls between predicate devices (400 μA and 900 μA) and well below the IEC 60601-2-10 limit of 50mA. |
| Maximum Output Current Density | 0.56mA/cm² @ 500Ω. Slightly higher than some predicates but significantly lower than Predicate Device 3 (8.8 mA/cm²) and the IEC 60601-2-10 noted trigger level of 2 mA/cm². |
| Maximum Power Density | 151 μW/cm². Significantly lower than Predicate 2 (4.18 mW/cm²) and Predicate 3 (39,600 μW/cm²), considered a safety advantage. |
| Maximum Phase Charge | 45.6 μC@500Ω. Higher due to longer pulse width, but offset by lower output current and balanced biphasic waveform for zero net output, operating within safety limits. |
2. Sample size used for the test set and the data provenance
The document specifies "production-equivalent devices" were used for bench testing. It does not provide a specific sample size (N=?) for these test devices.
The data provenance is based on internal testing conducted by GESKE Beauty Tech GmbH and evaluation by a "third-party accredited laboratory." The country of origin for these tests is not explicitly stated, but the submitter is based in Berlin, Germany. The testing described is prospective in nature, as it involves newly conducted tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for any performance claims related to cosmetic efficacy. The "ground truth" for the technical and safety performance is established by compliance with international standards (e.g., IEC, ISO) and comparison to legally marketed predicate devices, which are assessed by regulatory bodies. The qualifications of personnel conducting the internal and third-party laboratory tests are implied by their accreditation to perform such standards-based evaluations, but specific expert details are not provided.
4. Adjudication method for the test set
No adjudication method (e.g., 2+1, 3+1) is described, as the testing focuses on objective measurements against engineering specifications and compliance with recognized safety standards, rather than subjective interpretation or consensus-based clinical assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was conducted. The device is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on cosmetic efficacy (e.g., "face-lifting" ability) was not conducted or reported. The "standalone" performance here refers to the device's technical specifications and safety compliance, which were evaluated in bench tests and by a third-party laboratory without human interaction for performance claims beyond safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is primarily defined by:
- Compliance with international standards: (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, IEC 60529, IEC 62366, etc.) for electrical safety, EMC, biocompatibility, usability, and risk management.
- Technical specifications: Measurements of output characteristics (voltage, current, density, waveform) against design tolerances.
- Substantial equivalence to predicate devices: Comparing its technical characteristics and safety profile to legally marketed devices.
There is no mention of ground truth established by expert consensus, pathology, or cosmetic outcomes data for the device's "face-lift" claims in this 510(k) summary.
8. The sample size for the training set
This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable.
9. How the ground truth for the training set was established
This information is not applicable as the device does not utilize a training set in the context of AI/machine learning.
FDA 510(k) Clearance Letter - SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 23, 2025
GESKE Beauty Tech GmbH
Natalia Reshetnikova
Quality Manager
Leipziger Platz 18
Berlin, 10117
Germany
Re: K250361
Trade/Device Name: SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: NFO
Dated: February 6, 2025
Received: February 10, 2025
Dear Natalia Reshetnikova:
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.
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"
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K250361 - Natalia Reshetnikova Page 2
(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-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).
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K250361 - Natalia Reshetnikova Page 3
Sincerely,
Tushar Bansal -S
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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K250361
Please provide the device trade name(s).
SmartAppGuided MicroCurrent Face-Lift Pen | 6 in 1
Please provide your Indications for Use below.
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
Please select the types of uses (select one or both, as applicable).
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
SmartAppGuided MicroCurrent Face-Lift Pen | 6 in 1 Page 10 of 68
Page 5
GESKE Beauty Tech GmbH Premarket Notification
SmartAppGuided MicroCurrent Face-Lift Pen | 6 in 1
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of GESKE Beauty Tech GmbH knowledge.
1. Submitter
| Submitter: | GESKE Beauty Tech GmbH |
|---|---|
| Address: | Leipziger Platz 18, 10117, Berlin, Germany |
| Phone: | +4930209674837 |
| Email: | compliance@geske.com |
| Contact Person: | Natalia Reshetnikova |
| Date Prepared: | May 22, 2025 |
2. Device
| Type of 510(k) Submission: | Traditional |
|---|---|
| Device Trade Name: | SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 |
| Device Common or Usual Name: | Face-Lift Pen |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulatory Class: | Class II |
| Product Code: | NFO |
3. Predicate Devices
| Name of Device: | NūFACE® Trinity |
|---|---|
| 510 (k) Number: | K181008 |
| Name of Device: | NuBODY Skin Toning Device |
|---|---|
| 510 (k) Number: | K171588 |
| Name of Device: | PureLift Pro Plus |
|---|---|
| 510 (k) Number: | K221443 |
Page 6
4. Device Description
SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere.
The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.
5. Intended Use/Indications for Use
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
Page 7
6. Technological Characteristics Comparison
Comparison Tables 2A through 2D: Subject vs. Predicate Devices
Table 2A: General Information and Indication for Use Comparison Table
| Elements of Comparison | Subject Device | Predicate Device (1) | Predicate Device (2) | Predicate Device (3) |
|---|---|---|---|---|
| Company | GESKE Beauty Tech GmbH | Carol Cole Company dba NuFACE | Carol Cole Company dba NuFACE | Xtreem Pulse LLC |
| Trade Name | SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 | NuFACE Trinity | NuBODY Skin Toning Device | PureLift Pro Plus |
| 510(k) Number | K250361 | K181008 | K171588 | K221443 |
| Regulation Number (A1) | 21 C.F.R. § 882.5890 | Same as subject device | Same as subject device | Same as subject device |
| Regulation Name (A2) | Transcutaneous electrical nerve stimulator for pain relief | Same as subject device | Same as subject device | Same as subject device |
| Regulatory Class (A3) | Class II | Same as subject device | Same as subject device | Same as subject device |
| Product code (A4) | NFO | Same as subject device | Same as subject device | Same as subject device |
| Prescription or OTC (A5) | OTC | Same as subject device | Same as subject device | Same as subject device |
| Intended Use (A6) | SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use. | Same as subject device | NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic use. |
| Indications for Use (A7) | SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use. | Same as subject device | NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic use. |
| Anatomical Sites (A8) | Face and Neck | Same as subject device | Areas of the body other than the face | Face |
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Table 2B: Physical Characteristics Comparison Table
| Elements of Comparison | Subject Device | Predicate Device (1) | Predicate Device (2) | Predicate Device (3) |
|---|---|---|---|---|
| Dimensions of Device (B1) | Approx. 1.14" x 0.99" x 3.9" (Model: GK series) | 2.8" x 5.1" x 1.3" | 2.75" x 6.5" x 6.0" | 20.7cm x 4.8cm x 4.5cm |
| Weight (B2) | Approx. 1.3 oz. | 9 oz. without charging base | Approximately 10-14 oz. without a power adapter | Unknown |
| Housing Materials of Main Unit (B3) | ABS & silicone | Thermoplastic | Thermoplastic | Unknown |
| Spheres (B4) | Stainless steel polished or with black chrome or yellow titanium gold plating | Chrome-plated | Chrome-plated | Unknown |
Table 2C: Technological Characteristic Comparison Table
| Elements of Comparison | Subject Device | Predicate Device (1) | Predicate Device (2) | Predicate Device (3) |
|---|---|---|---|---|
| Power Source (C1) | Internal rechargeable battery | Same as subject device | Same as subject device | One 3.7V Battery |
| Method of Line Current Isolation (C2) | Type BF | Same as subject device | Same as subject device | Same as subject device |
| Patient Leakage Current (C3) | ||||
| 1). Normal condition | N/A – Battery operated | Same as subject device | Same as subject device | Unknown |
| 2). Single fault condition | N/A – Battery operated | Same as subject device | Same as subject device | Unknown |
| External power adapter (C4) | User supplied standard 5-volt USB port | NuFACE 7-volt power adapter | NuFACE 5-volt power adapter | Unknown |
| Number of Output Channels (C5) | 1 | Same as subject device | Same as subject device | Same as subject device |
| Synchronous or Alternating (C6) | N/A - 1 Output Channel | Same as subject device | Same as subject device | Same as subject device |
| Method of Channel Isolation (C7) | N/A - 1 Output Channel | Same as subject device | Same as subject device | Same as subject device |
| Regulated Current or Regulated Voltage (C8) | Both | Same as subject device | Same as subject device | Regulated current |
| Software/Firmware (C9) | Yes | Same as subject device | Same as subject device | Same as subject device |
| Automatic Overload Trip (C10) | Not required due to circuit design | Same as subject device | Same as subject device | Unknown |
| Automatic No Load Trip (C11) | Yes | Same as subject device | Same as subject device | Unknown |
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| Automatic Shut Off (C12) | Yes | Same as subject device | Same as subject device | Same as subject device |
| Patient Override Control (C13) | Yes | Same as subject device | Same as subject device | No |
| Indicator Display (C14) | No | Yes | Yes | Yes |
| On/Off Status (C15) | Yes | Same as subject device | Same as subject device | Same as subject device |
| Low Battery (C16) | Yes | Same as subject device | Same as subject device | Unknown |
| Voltage/Current Level (C17) | Yes | Same as subject device | Same as subject device | Unknown |
| Automatic Shut-Off (minutes) (C18) | Yes (3 min) | Yes (20 min) | Yes (5 min) | Unknown |
| Compliance with Voluntary Standards (C19) | IEC 60601-1IEC 60601-1-2IEC 60529IEC 60601-2-10ISO 14971IEC 60601-1-6IEC 62366IEC 60601-1-11ANSI/AMI ES60601-1CAN/CSA-C22.2 No. 60601-1IEC 62133 | IEC 60601-1IEC 60601-1-2Same as subject device | ANSI/AAMI ES60601-1 IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 |
| Compliance with 21 CFR 898 (C20) | Yes | Same as subject device | Same as subject device | Unknown |
Table 2D: Output Characteristics Comparison Table
| Elements of Comparison | Subject Device | Predicate Device (1) | Predicate Device (2) | Predicate Device (3) |
|---|---|---|---|---|
| Waveform (e.g., pulsed monophasic, biphasic) (D1) | Pulsed Biphasic | Same as subject device | Monophasic waveform that is delivered in a burst of pulses | Pulses Monophasic, alternating polarity |
| Shape (D2) | Modulated Square | Same as subject device | Same as subject device | Rectangular Pulses |
| Maximum Output Voltage (D3) | 25.2VDC (No Load)0.38V @500Ω1.5 V @2kΩ6.0V @10kΩ | 28 VDC | 28 VDC | 20Vpp(@500Ω)32Vpp(@2kΩ)44Vpp(@10kΩ) |
| Maximum Output Current (D4) | 760μA@500Ω750 μA @2kΩ600 μA @10kΩ | 400 μA @ 500ΩUnknown (@2kΩ)Unknown (@10kΩ) | 900 µA @ 500ΩUnknown (@2kΩ)Unknown (@10kΩ) | 9mA(@500Ω)4.4mA(@2kΩ)1.2mA(@10kΩ) |
| Maximum Output Current Density (D5) | 0.56mA/cm2 @ 500Ω | 0.419 mA/cm2 | 0.468 mA/cm2 | 8.8mA/cm2 @500Ω |
| Output Current when not stimulating (D6) | < 1 µA | Same as subject device | Same as subject device | Unknown |
| Output Tolerance (D7) | +/- 10% | Same as subject device | Same as subject device | +/- 1mA |
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| Pulse Width (D8) | 60ms | Same as subject device | Same as subject device | 4µs |
| Output Frequency (D9) | Approx. 8.3 Hz | Same as subject device | Same as subject device | 1.37kHz～1.73kHz |
| For interferential modes, only (D10) | | | | |
| a. Beat Frequency (Hz) | No Beat Frequency | Same as subject device | Same as subject device | Unknown |
| For multiphasic waveforms, only (D11) | | | | |
| a. Symmetrical phases | Not Multiphasic | Same as subject device | Same as subject device | Same as subject device |
| b. Phase Duration (include units) c. (state range, if applicable) d. (both phases, if asymmetrical) | Not Multiphasic | Same as subject device | Same as subject device | Same as subject device |
| Net Charge (D12) | N/A - Battery operated | Same as subject device | 54 µC per pulse | 0μC per pulse train |
| Type of Energy Output (D13) | Microcurrent | Same as subject device | Same as subject device | Unknown |
| Pulses per burst (D14) | 20 | Same as subject device | Same as subject device | 30 |
| Pulses per second (D15) | 8.3 | Same as subject device | Same as subject device | Unknown |
| Burst duration (s) (D16) | 2.4s | Same as subject device | Same as subject device | Unknown |
| Duty Cycle (D17) | 50% | Same as subject device | 20.2 s | Unknown |
| Maximum Power Density (D18) | 151 μW/cm2 | Unknown | 4.18 mW/cm2 | 39600μW/cm2 |
| Maximum Phase Charge (D19) | 45.6 μC@500Ω | Unknown | 1.08 mC/Burst | 5.81μC@500Ω |
| Pulse ON time (D20) | 60 msec | Same as subject device | Same as subject device | Unknown |
| Pulse OFF time (D21) | 60 msec | Same as subject device | Same as subject device | Unknown |
The following technological differences exist between the subject and predicate devices:
Dimensions of Device (B1) and Weight (B2)
Although the dimensions and net weight of the subject device differ slightly from those of the predicate device, all devices fall under the category of electrical devices designed for home use. These variations in size and weight do not affect the device's effectiveness or compromise its safety.
Housing Materials of Main Unit (B3)
The housing materials of the main unit in the subject device are different from those in the predicate device. To ensure safety, the subject device underwent comprehensive biocompatibility testing, including in vitro
Page 11
cytotoxicity, skin irritation, and skin sensitization tests. The results confirmed that the device does not cause adverse skin reactions.
Spheres (B4)
The materials used for the spheres in the subject device differ from those in the predicate device. Similar to the housing materials, the subject device underwent biocompatibility testing, including in vitro cytotoxicity, skin irritation, and skin sensitization tests. The test results demonstrated that the differences in materials do not cause adverse skin reactions.
Indicator Display (C14)
The subject device does not include an indicator display, while all predicate devices have this feature. Therefore, substantial equivalence has not been met in terms of indicator display. The subject device provides tactile and sound feedback through noise and vibration. These feedback mechanisms allow the user to identify the operational status of the device effectively, compensating for the lack of a visual indicator.
Maximum Output Voltage (D3):
The subject device has a maximum output voltage of 25.2VDC (no load), which is slightly lower than the 28VDC maximum output voltage of Predicate Devices 1 and 2. The lower voltage enhances safety, and this slight decrease does not introduce any safety risks for the subject device. Medical devices designed for microcurrent applications, such as the subject device, operate at low voltage levels to ensure patient safety.
Furthermore, the subject device complies with IEC 60601-1 and IEC 60601-2-10 standards, which rigorously assess electrical safety and performance. These differences result from design variations that do not introduce new risks or affect the device's intended use. The clinical need has been achieved through a combination of increased current levels.
Maximum Output Current (D4):
The subject device delivers a maximum output current of 760 μA at a 500Ω load, which falls between the output currents of the primary predicate device (400 μA) and the secondary predicate device (900 μA). Although the secondary predicate device operates at a higher current, this difference remains within the FDA's recommended ±20% threshold for demonstrating substantial equivalence.
Furthermore, the secondary predicate device is specifically designed for skin stimulation, has been FDA-cleared for over-the-counter (OTC) home use, and is legally marketed with no known history of recalls. Given the existence of an FDA-cleared and commercially available device with higher output parameters intended for similar OTC applications, we conclude that the difference in output current between the subject device and the primary predicate device does not raise any safety concerns.
In IEC 60601-2-10, the maximum output current is specified in clause 201.12.4.104 Limitation of output parameters:
With a load resistance of 500 Ω the output current shall not exceed the limits in Table 201.101: 50mA current limit for pulse frequencies ≤ 400 Hz.
Both values (𝐼𝑝𝑒𝑎𝑘 and 𝐼𝑅𝑀𝑆) of the subject device are significantly lower than the limit defined by the standard.
Furthermore, other devices cleared under the same FDA product code (NFO) exhibit even higher output currents. For instance, Predicate Device 3 demonstrates a maximum current of 9 mA at 500 Ω, substantially higher than both the subject device and the primary predicate.
Given the substantial margin between the subject device's output current and the IEC 60601-2-10 safety limit of 50 mA, the documented clearance of higher-current predicate devices by the FDA, and the presence
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of Predicate Device 2 exhibiting a current difference within the FDA's recommended ±20% threshold, we conclude that the current difference between the subject device and the primary predicate device does not raise any safety concerns.
Maximum Output Current Density (D5):
The subject device exhibits a maximum output current density of 0.56 mA/cm² at 500 Ω, which is slightly higher than those of Predicate Device 1 (0.418 mA/cm²) and Predicate Device 2 (0.468 mA/cm²) but remains significantly lower than that of Predicate Device 3 (8.8 mA/cm²). The difference in current density between the subject device and Predicate Device 2 does not exceed the ±20% threshold recommended by the FDA for substantial equivalence.
According to IEC 60601-2-10, Clause 201.4.2 and Clause 201.7.9.2.101, a current density limit of 2 mA/cm² is identified as a level that may require special operator attention. The subject device's output current density of 0.56 mA/cm² is approximately 3.57 times lower than this threshold.
Given the substantial margin between the subject device's maximum current density and the IEC 60601-2-10 safety limit of 2 mA/cm², the FDA clearance of predicate devices with higher current densities, and the fact that the current density of the subject device remains within the acceptable range (±20%) relative to Predicate Device 2, we conclude that the current density difference between the subject device and the primary predicate device does not present any safety concerns.
Maximum Power Density (D18):
The maximum power density of the subject device is significantly lower than that of Predicate Device 2 and 3, which exhibits a maximum power density of 4.18 mW/cm2 and 39,600 μW/cm² accordingly. This substantial reduction in energy output ensures that the subject device does not present an increased risk of thermal or electrical injury, nor does it introduce any new concerns related to safety.
In addition, the subject device has been demonstrated to be fully compliant with the applicable requirements of IEC 60601-1 and IEC 60601-2-10.
Maximum Phase Charge (D19):
The higher maximum phase charge of the subject device, compared to Predicate Device 3, is primarily attributable to its longer pulse width. Although the subject device delivers a greater charge per phase, this is offset by its significantly lower maximum output current. Despite the increased phase charge, the device operates well within established safety limits for stimulation.
Moreover, the subject device employs a biphasic waveform with actively balanced positive and negative phases, ensuring zero net output. This charge balancing is essential for minimizing the risk of tissue damage and long-term electrochemical effects.
In addition, both tested devices comply with the requirements of IEC 60601-1 and IEC 60601-2-10. The difference in maximum phase charge does not impact on essential performance, effectiveness, safety, or substantial equivalence.
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7. Non-Clinical Performance Testing
Safety Testing
SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 device was tested and has demonstrated compliance with applicable IEC standards concerning electrical safety and EMC.
Electrical, Mechanical, and Thermal Safety Testing were conducted according to the following standards:
- IEC 60601-1: Basic safety and essential performance (Electrical Equipment)
- IEC 60601-1-11: Basic safety and essential performance (Med Dev Home Use)
- IEC 60601-1-2: EMC - Basic safety and essential performance (Electromagnetic Disturbances)
- IEC 60601-1-6: Basic safety and essential performance (Med Dev Electrical Equipment)
- IEC 60601-2-10: Basic safety and essential performance (Med Dev Home Use – nerve and muscle stimulators)
- ISO 10993-1: Biological Evaluation of Medical Devices
- IEC 60529: Ingress Protection
- IEC 62366: Usability engineering
- ISO 14971: Risk Management
Bench Testing
Bench testing was conducted to verify that the MicroCurrent Face-Lift Pen | 6-in-1 meets established performance requirements and waveform specifications within the designed tolerances. Details are provided in the Performance Testing Section of this premarket notification.
Testing utilized production-equivalent devices to assess waveform and output energy characteristics. Additionally, a third-party accredited laboratory evaluated the device in accordance with IEC 60601-2-10, which specifies safety and performance requirements for nerve and muscle stimulators.
Results from both internal and independent testing confirm that the waveform and energy characteristics of the MicroCurrent Face-Lift Pen | 6-in-1 conform to intended specifications and demonstrate substantial equivalence to the predicate device.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff", issued on June 14, 2023. The software for this device was considered as a "basic" level of concern, since a failure or latent flaw in the software could not result in injury or death to the patient or operator.
Animal Study
Animal study was not required to demonstrate the substantial equivalence to the predicate devices.
Biocompatibility
The biocompatibility evaluation for the patient contacting components of the SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". Tests in accordance with the following standards were conducted based on contact type and duration:
- ISO 10993-1:2018
- ISO 10993-5:2009
- ISO 10993- 10:2021
- ISO 10993-12:2021
- ISO 10993-23:2021
8. Clinical Performance Data:
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
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9. Conclusions
The subject device, the MicroCurrent Face-Lift Pen, manufactured by Geske Beauty Tech GmbH, and the predicate devices—the NuFACE Trinity (510(k) Number: K181008), NuBODY Skin Toning Device (510(k) Number: K171588) and PureLift Pro Plus (510(k) Number: K221443)—share a similar intended use. A comprehensive comparison and assessment of the differences between the subject device and all predicate devices are detailed in Tables 2A through 2D.
Biological evaluation data, software data, electrical safety and electromagnetic compatibility (EMC) data, along with bench-top performance testing, demonstrate that the subject device is as safe and effective as the predicate devices. Based on these analyses, it is concluded that substantial equivalence between the subject and predicate devices has been established.
§ 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).