The Sunny Plus device is a Low Frequency Electric Stimulator that conveys current to the human body through a non-invasive electrode with a frequency of 10Hz. It is composed of the main body, handpiece with electrode tip, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.

AI/ML Overview

N/A

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

September 18, 2025

ShenB Co., Ltd
℅ Aubrey Thompson
Regulatory Consultant
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento, California 95825

Re: K251649
Trade/Device Name: Sunny Plus (Sunny)
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: NFO
Dated: August 25, 2025
Received: August 26, 2025

Dear Aubrey Thompson:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251649 - Aubrey Thompson
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-

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K251649 - Aubrey Thompson
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tushar Bansal -S

Tushar Bansal, PhD
Acting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K251649

Device Name
Sunny Plus (Sunny)

Indications for Use (Describe)
Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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."

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510(K) Summary

Sunny Plus (K251649)

Sponsor: ShenB Co., Ltd.
Sponsor Address: SHENB Tower, 74, Achasan-ro, Seongdong-gu, Seoul, Republic of Korea
Sponsor Phone Number: 82-2-4660010
Regulatory Contact Person: Aubrey Thompson, Regulatory Consultant
Contact Information: aubreythompson@hoyregulatory.com, (530) 980-1602
Preparation Date: September 5, 2025
Device Name: Sunny Plus
Model Name: Sunny
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
Regulation Number: 882.5890
Product Code: NFO
Regulatory Class: II
Legally Marketed Predicate Devices: TAMA BEMS (K173093)

Device Description:

Indications for use:

Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

Substantial Equivalence—Indications for use and Technical Comparison

Indications for Use Comparison

Sunny Plus K251649	TAMA BEMS K173093	Comparison
Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.	The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes	Same

Technical Specifications Comparison

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510(K) Summary

Sunny Plus (K251649)

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510(K) Summary

Sunny Plus (K251649)

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510(K) Summary

Sunny Plus (K251649)

| Frequency (Hz) | 10Hz | 0.045 – 2560 Hz | The frequency of the subject device is within the Frequency range of the predicate device. The predicate device has significant variability in its frequency, whereas the subject device has a fixed frequency. |
| Net Charge (microcoulombs(µC) per pulse) (If zero, state method of achieving zero net charge.) | 0 @ 500Ω biphasic waveform Zero net charge is achieved by using symmetrical biphasic waveforms | 0μC @500 Ω | Same |
| Maximum charge per Phase, (µC) | 8.5µC positive phase, 8.5µC positive phase (0.4% duty cycle), all loads | 400 µC positive phase, 400 µC positive phase, (50% duty cycle), all loads | Different. The subject device generally delivers a lower stimulation than the predicate. The lower maximum charge per phase is safer for patients. |
| Maximum Current Density, (mA/cm²) | 0.00354 mA/cm2 @ 500Ω | 1.591 @500 Ω | Different |
| Maximum Power Density (W/cm²), | 0.000376302 @500Ω | 318E-6 @500Ω0.012 @18.75 KΩ | similar. |
| Burst Mode (i.e., pulse trains): | N/A no burst mode | Pulses per burst - 5 - 20Bursts per second - 10 - 40Burst duration (seconds) 0.00195 – 0.0078Duty Cycle: Line (b) x Line (c) 0.0195 – 0.1719 | Different. The subject device does not contain a burst mode. |

Performance Testing

Verification and validation activities were successfully completed and establish that the Sunny™ performs as intended. Testing included the following:

IEC 60601-1:2005 + A2:2020; Medical Electrical Equipment- Part 1: General Requirements For Basic Safety And Essential Performance

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510(K) Summary

Sunny Plus (K251649)

IEC 60601-1-2:2014 + A1:2020; Medical Electrical Equipment- Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-2-10 + A2:2023; Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 62304:2006+A1:2015; Medical Device – Software Life Cycle Processes
EN ISO 14971:2012; Medical Devices – Application Of Risk Management To Medical Devices
IEC TR 60601-4-2 Edition 1.0 2016-05: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Bench testing was performed to verify the accuracy of the output power, current, and pulse width.

Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.

Biocompatibility – Patient contacting materials have been determined to be biocompatible.

Discussion

The Sunny Plus and the predicate device, TAMA BEMS, have the same principle of operation and the same essential performance characteristics: output voltage and frequency. The two devices function slightly differently, but not in a way that impacts device safety or effectiveness. The TAMA BEMS has multiple electrodes that can moved across a patient's face or be affixed to it, whereas the Sunny Plus has a single electrode that can be moved across the patient's face. The patient has no control during treatment, unlike the predicate device, making some patient-facing safety measures not applicable to the Sunny. The predicate device has a wider range of frequency than the Sunny Plus, with the Sunny Plus' 10Hz frequency falling at the lower end of the range. The pulse width, current, and current density of the two devices are different. The shorter pulse width of the Sunny Plus provides greater patient comfort, and the lower current delivers a lower sensation to the patient, while still stimulating tissue. These differences translate into higher levels of stimulation for the TAMA BEMS when used at these higher levels. Generally, the Sunny Plus has a subtler impact on nerve stimulation. The other differences in the devices do not impact the device safety or efficacy. Based on a comparison of indications for use, technological characteristics and performance data, it can be concluded that the Sunny Plus device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).