(102 days)
Not Found
No.
The device description and performance testing indicate it is a microcurrent stimulation device with fixed functionality, and there are no mentions of AI, machine learning, or similar technologies.
No
The device is described as being "intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use," and its description explicitly states it is an "over-the-counter stimulation device." The documented intended use focuses on cosmetic application rather than treating or diagnosing a medical condition.
No
The device is intended for stimulation of neck and facial skin for over-the-counter cosmetic use and delivers microcurrent pulses; it does not mention any diagnostic functions or capabilities.
No
The device is not a software-only medical device. The description clearly states it is a physical "stimulation device" with an "injection-molded thermoplastic resin enclosure," "electrode composed of chrome-plated or titanium-gold plated sphere," and is "powered by a rechargeable lithium-ion battery." It "produces microcurrent that is discharged through two fixed, smooth spherical electrodes." These are all hardware components.
No.
The device is described as an over-the-counter stimulation device intended for "stimulation of neck and facial skin" and "over-the-counter cosmetic use," which delivers microcurrent. There is no indication that it is used for in vitro examination of specimens derived from the human body.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
NFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neck and facial skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter use, home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Testing: Electrical, Mechanical, and Thermal Safety Testing were conducted according to IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, ISO 10993-1, IEC 60529, IEC 62366, ISO 14971, IEC 62133.
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. Testing utilized production-equivalent devices to assess waveform and output energy characteristics. A third-party accredited laboratory evaluated the device in accordance with IEC 60601-2-10. Results confirm that the waveform and energy characteristics conform to intended specifications and demonstrate substantial equivalence to the predicate device.
Software Verification and Validation Testing: Software verification and validation testing were conducted 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 was considered a "basic" level of concern.
Animal Study: Not required.
Biocompatibility: Evaluation performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1". Tests conducted in accordance with ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-12:2021, ISO 10993-23:2021.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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"
Page 2
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).
Page 3
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 |
Page 8
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 |
Page 9
| 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 60601-1
IEC 60601-1-2
IEC 60529
IEC 60601-2-10
ISO 14971
IEC 60601-1-6
IEC 62366
IEC 60601-1-11
ANSI/AMI ES60601-1
CAN/CSA-C22.2 No. 60601-1
IEC 62133 | IEC 60601-1
IEC 60601-1-2
Same as subject device | ANSI/AAMI ES60601-1 IEC 60601-1-2
IEC 60601-2-10
IEC 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 @500Ω | ||||
| 1.5 V @2kΩ | ||||
| 6.0V @10kΩ | 28 VDC | 28 VDC | 20Vpp(@500Ω) | |
| 32Vpp(@2kΩ) | ||||
| 44Vpp(@10kΩ) | ||||
| Maximum Output Current (D4) | 760μA@500Ω | |||
| 750 μA @2kΩ | ||||
| 600 μA @10kΩ | 400 μA @ 500Ω | |||
| Unknown (@2kΩ) | ||||
| Unknown (@10kΩ) | 900 µA @ 500Ω | |||
| Unknown (@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) |