Sunny

K242241 · ShenB Co., Ltd. · GEI · Mar 19, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K242241
• Device Name: Sunny
• Applicant: ShenB Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis. The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

Device Story

Sunny is a high-frequency electrosurgical unit for non-invasive dermatologic and therapeutic use. It utilizes three RF frequencies (6.78MHz, 1MHz, 2MHz) delivered via two handpieces: Sunny (monopolar) and Pulsar (monopolar/bipolar). The system includes a main console with an LCD graphic user interface, treatment tips, neutral electrode pad, refrigerant gas, and foot switch. Operated by medical professionals in a clinical setting, the device conveys RF current to the body to induce thermal effects. The Sunny handpiece performs electrocoagulation and hemostasis; the Pulsar handpiece provides topical heating to elevate tissue temperature (40-45°C) for pain relief and circulation. The device features 'Soft' and 'Hard' modes to manage power delivery and patient comfort. Healthcare providers use the interface to select power levels and modes, directly impacting the thermal energy delivered to the patient's skin. Benefits include controlled tissue heating for therapeutic relief and surgical hemostasis.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing, including RF energy accuracy verification, histopathology to demonstrate thermal effects, and temperature maintenance testing (confirming 40-45°C maintenance for 10 minutes). Biocompatibility was established per ISO 10993-1.

Technological Characteristics

High-frequency electrosurgical unit; 6.78MHz, 1MHz, 2MHz RF; Monopolar and Bipolar delivery. Materials are biocompatible (ISO 10993-1). Single-use, non-sterile electrode tips. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, EN ISO 14971. Connectivity via LCD interface.

Indications for Use

Indicated for dermatologic electrocoagulation and hemostasis (6.78MHz RF) and topical heating for temporary pain relief, muscle spasms, and increased local circulation (1MHz/2MHz RF).

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Thermage CPT (K173759)

Reference Devices

• Nuera Tight (K210867)

Submission Summary (Full Text)

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March 19, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K242241

Trade/Device Name: Sunny Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, NFO, PBX Dated: February 18, 2025 Received: February 18, 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.

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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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (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-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 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 Rue"). 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-device-advice-comprehensiveregulatory-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-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Image /page/2/Figure/3 description: The image shows the name James H. Jang-S. To the right of the name, it says "Digitally signed by James H. Jang -S". Below that, it says "Date: 2025.03.19 00:00:52 -04'00'".

For

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K242241

Device Name Sunny

Indications for Use (Describe)

The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis.

The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

Type of Use (Select one or both, as applicable)

| <span style="font-family:Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------|
| <span style="font-family:Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Applicant<br>Address | ShenB Co., Ltd.<br>SHENB Tower, 74, Achasan-ro, Seongdong-gu, Seoul, Korea,<br>Republic of |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person | Aubrey Thompson, Regulatory Consultant |
| Contact Information | [e-mail] |
| Preparation Date | March 17, 2025 |
| Device Trade Name<br>K Number<br>Classification Name<br>Regulation Number<br>Product Code<br>Regulatory Class | SunnyTM<br>K242241<br>Electrosurgical Cutting and Coagulation Device and Accessories<br>878.4400<br>GEI, PBX<br>II |
| Legally Marketed Predicate Device<br>Reference Device | Thermage CPT (K173759)<br>Nuera Tight |

### Device Description:

The Sunny device is a high frequency electrosurgical unit that conveys current to the human body through non-invasive electrodes. The device includes three different high frequencies: 6.78MHz (RF), 1MHz (RF), and 2 MHz (RF). It is composed of the main body, Sunny handpiece, Pulsar handpiece, treatment tips, neutral electrode pad, refrigerant gas, 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.

### Indications for use:

The Sunny device has different indications for use according to its different modes.

The Sunny RF Handpiece (6.78 MHz) is indicated for dermatologic procedures for electrocoagulation and hemostasis.

The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

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### Indications for Use Comparison

| Indications for Use Comparison | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sunny TM (Subject Device) | Thermage CPT (K173759) | Nuera Tight RF (K210867) | Comparison |
| The Sunny RF Handpiece (6.78MHz) is indicated for dermatologic procedures for electrocoagulation and hemostasis. The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. | The radiofrequency energy delivery components of the Thermage CPT System and Accessories are indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT System and Accessories are indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids; Non-invasive treatment of wrinkles and rhytids; | Provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation; to provide, with a massage device, a temporary reduction in the appearance of cellulite. | The subject device and predicate device share the electrocoagulation and pain relief indications for RF devices. The Sunny RF handpiece has not been tested for wrinkle related indications and therefore does not include them in this submission.<br><br>The subject device has the same indications for use as the reference device. |

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| 510(K) Summary<br>Sunny™<br>K242241 | | | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Temporary improvement in the appearance of cellulite; Relief of minor muscle aches and pains; Relief of muscle spasms; Temporary improvement of local circulation (i.e., blood circulation). | | | |

### Technical Characteristics Comparison

| SUNNY Handpiece Technical Specifications Comparison | | | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | Sunny™ (Subject Device) | ThermageCPT (Predicate Device) | Comparison |
| Energy Delivery | Sunny Handpiece: Monopolar<br>Radiofrequency | Monopolar Radiofrequency with<br>vibration | Same. |
| Frequency | Sunny Handpiece: 6.78 MHz | 6.78 MHz | Same. |
| Max power | Sunny Handpiece:<br>120 W | 400 W | Different. Thermal Effects testing<br>demonstrates effectiveness of the Sunny<br>device at lower max power and desirable<br>clinical effects from both devices as clinically<br>relevant settings. See discussion below. |
| Energy Output | 25 to 135 Joules | 20 to 137 Joules | Similar. The small differences do not impact |
| Range | K242241 | | the safety or effectiveness of the subject<br>device. |
| Electrode size | 2.25 cm2 | 0.25 cm2, 3.0 cm2, and 16.0 cm2 | The treatment area of the predicate device is<br>slightly larger than the subject. Other tips are<br>included with the Thermage that are not<br>included with the Sunny. |
| Pulse width | 1140ms | 100-2000 pulses delivered during<br>treatment (length of pulse is<br>unknown) | Different, but overall energy output range is<br>nearly the same. |
| Power Density | 53.3 J/cm² | 45.6J/cm² | Similar. The slight difference in electrode size<br>creates the difference in power density, but<br>the overall output energy range is very<br>similar. |
| Energy Levels | 16 power levels<br>Level 0.5 = 20W @400Ω rated load<br>Level 8.0 = 120W @400Ω rated load | 19 power levels | similar |
| Duty Cycle | 81.4%, intermittent Use | 50%, intermittent Use | Different. Overall energy output range is<br>nearly the same and the difference does not<br>introduce any safety issues. |
| Operating<br>modes | Soft mode- gradually increased power<br>during a single pulse<br>Hard mode – full power delivered (at<br>selected level) during a single pulse | N/A | Different. Predicate device does not have a<br>soft mode function. This does not impact<br>safety or effectiveness, it is only intended to<br>increase patient comfort. |
| Sterilization | Electrode tips are single use, not<br>provided sterile | Electrode tips are reusable, not<br>provided sterile | Neither device utilizes sterile tips, but the<br>predicate device requires pre-use cleaning. |
| Biocompatibility | Materials contact intact patient skin<br>with a contact duration of under 24 | Materials contact intact patient<br>skin with a contact duration of | Same. |

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| hours. Materials have been<br>determined to be biocompatible<br>through testing. | under 24 hours. Materials have<br>been determined to be<br>biocompatible. |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------|
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------|

| Pulsar Handpiece Technical Specifications Comparison | | | | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sunny Device, Pulsar<br>Handpiece | Thermage CPT (Predicate<br>Device) | Nuera Tight RF<br>(Reference Device) | Comparison |
| Energy Delivery | Monopolar and Bipolar<br>Radiofrequency | Monopolar<br>Radiofrequency with<br>vibration | Monopolar and Bipolar<br>Radiofrequency | The subject and predicate<br>devices contain<br>monopolar functionality.<br>The Sunny Device also<br>contains bipolar<br>functionality. This does<br>not impact the safety and<br>efficacy of the device.<br>The subject and reference<br>devices both have<br>monopolar and bipolar<br>functionality. |
| Frequency | 1MHz, 2MHz | 6.78MHz | 470 kHz; 1 MHz; 2 MHz; 4<br>MHz; 6 MHz | Different. Tissue<br>temperature testing<br>demonstrates that the<br>devices can perform<br>equivalently.<br>The subject devices share<br>the 1Mhz and 2MHz<br>frequencies with the<br>reference device. |
| Max power | 40.5W at 1MHz | 400W (treatment is | 250W | Max power is higher with |
| | 20.2W at 2MHz | recommended at lower<br>power) | | the predicate device.<br>However, Thermage<br>labeling recommends<br>using a lower power to<br>ensure patient comfort.<br>Side by side testing was<br>conducted at power levels<br>that were similar for the<br>two devices and<br>demonstrates comparable<br>performance. |
| Pulse Width | 100 msec ~ 800 msec ±<br>10% | Unknown | Unknown | The exact pulse width of<br>the predicate is unknown,<br>but the output energy is<br>very similar between the<br>devices. |
| Sterilization | Not sterile | Not sterile | One handpiece is sterile<br>(ETO), other handpieces<br>are not provided sterile | Same |
| Patient Contacting<br>Materials | Intact skin contacting<br><24 hours<br>Determined<br>biocompatible through<br>testing | Intact skin contacting<br><24 hours<br>Determined<br>biocompatible | Intact skin contacting<br><24 hours<br>Determined<br>biocompatible | Same |
| Performance goals | Temporary pain relief and<br>increased circulation<br>through topical heating.<br>Maintenance of<br>therapeutic temperature<br>(40-43°C) for 10 mins of<br>treatment. | Temporary pain relief and<br>increased circulation<br>through topical heating. | Temporary pain relief and<br>increased circulation<br>through topical heating.<br>Maintenance of<br>therapeutic temperature<br>(40-42°C +/- 2°C) for 15<br>mins of treatment. | Testing performance goals<br>are the same for the<br>subject and reference<br>devices. Subject and<br>Predicate devices share<br>the same indications for<br>use and performance<br>testing demonstrates the<br>predicate device can<br>perform the same when |
| | | | | subjected to the same<br>test methods as the Sunny<br>device. |
| Energy levels | 10 levels<br>Level 1:<br>1MHz: 15.2 W @ 200 Ω<br>2 MHz: 7.6W @200 Ω<br><br>Level 10:<br>1 MHz: 40.5W @200 Ω<br>2 MHz: 20.2W @200 Ω | 19 levels | | The exact energy used at<br>various levels for the<br>predicate is not known. |
| Power density (total<br>power per unit of area) | 60 J/cm² | 45.6J/cm² | | Similar. |
| Tip configuration (pin<br>spacing penetration,<br>power each pin) | Blazar Cartidge: Flat,<br>Square electrodes<br>2.25 cm²<br><br>Quasar Cartridge: square<br>electrodes with raised<br>individual electrode pins,<br>25 or 36 pins,<br>corresponding to<br>1.62 W/Pin or<br>1.13 W/Pin.<br><br>Electrode size: 2.33cm2 | Flat square electrodes,<br>0.25 cm2, 3.0 cm2, and<br>16.0 cm2 | 3.15cm², 7cm², 12.5cm²,<br>28.25cm², 38.5cm²,<br>78.5cm2 | The 2.25 cm electrode is<br>similar to the 3.0 cm<br>electrode of the predicate<br>device. The different sizes<br>available with the<br>Thermage are not<br>available with the Sunny.<br><br>The subject and reference<br>device have slightly<br>different designs. The<br>reference device<br>electrodes are circular<br>and all flat. The smallest<br>electrode of the reference<br>device is similar in size to<br>the Pulsar electrodes. |
| Operational modes<br>pulse/continuous pulse<br>cycles | Pulsed | Pulsed | Continuous | Same as predicate. |
| Treatment duration | 10 minutes | unknown | 15 minutes | Similar to reference device. |
| polarity | Monopolar, bipolar,<br>combination of<br>monopolar and bipolarity<br>at varying ratios | Monopolar | Monopolar and bipolar<br>electrodes | Both devices include<br>monopolar functionality.<br>The predicate device does<br>not contain bipolar<br>functionality. The bipolar<br>function of the Sunny<br>device is intended to<br>provide flexibility in<br>treatment options for the<br>practitioner and does not<br>impact the safety or<br>effectivenes<br>s of the device. |

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### 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
- . 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 60601-2-2:2017 + A1:2023; Medical Electrical Equipment -part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
- IEC 62304:2006+A1:2015; Medical Device - Software Life Cycle Processes
- EN ISO 14971:2019; 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
- . ISO 10993-1:2018 - Biological Evaluation of Medical Devices

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 RF energy. Histopathology testing was conducted to demonstrate the thermal effect of the device. A test summary is provided below.

A temperature maintenance test was performed for the Pulsar Handpiece and confirmed that the device can maintain skin temperature of 40°C-45°C for 10 minutes.

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

### SUNNY RF Handpiece

The Sunny RF function at 6.78MHz shares the same general design, frequency, and intended use as the predicate, the Thermage CPT. The devices have the same frequency, but different maximum power outputs and slightly different electrode sizes. Thermal testing with the Sunny demonstrated that the device functions comparatively to the predicate. Based on the similarities between the two devices and the evidence of effectiveness provided by the thermal testing, the two devices can be considered substantially equivalent.

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#### PULSAR RF Handpiece:

The Pulsar RF function shares the same intended use, mechanism of action, and general design as the predicate device. The two devices differ in output power and frequency, tissue temperature maintenance testing confirmed the device can maintain skin temperature of 40°C-45°C for 10 minutes of treatment on three different anatomical sites.

#### Conclusion:

Based on a comparison of indications for use, technological characteristics and performance data; it can be concluded that both the Sunny RF and Pulsar handpieces of the Sunny Device are substantially equivalent to the predicate device.