(231 days)
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 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.
Based on the provided text, the device in question is an electrosurgical unit (Sunny™) and not an AI-powered diagnostic device. Therefore, a significant portion of the requested information, such as multi-reader multi-case (MRMC) comparative effectiveness studies, ground truth establishment by experts, and sample sizes for training/test sets related to AI model validation, are not applicable.
The acceptance criteria and study that proves the device meets them are focused on hardware performance, safety, and substantial equivalence to a predicate device.
Here's an organized description of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Sunny™ (Electrosurgical Cutting and Coagulation Device and Accessories)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit/Explicit from Text) | Reported Device Performance/Testing Result |
|---|---|
| Device Performance (Sunny RF Handpiece - 6.78MHz) | |
| Effectiveness for electrocoagulation and hemostasis (based on thermal effect) | Histopathology testing conducted to demonstrate the thermal effect of the device, showing it functions comparatively to the predicate (Thermage CPT) despite differences in max power and electrode size. |
| Energy Output Range (25 to 135 Joules) | Achieved. "Similar" to predicate's 20 to 137 Joules, with the small differences not impacting safety or effectiveness. |
| Device Performance (Pulsar Handpiece - 1MHz and 2MHz RF) | |
| Ability to provide topical heating for temporary relief of pain, muscle spasms, and increase in local circulation (based on temperature maintenance) | A temperature maintenance test was performed and confirmed that the device can maintain skin temperature of 40°C-45°C for 10 minutes on three different anatomical sites. The performance goal for the reference device (Nuera Tight RF) was 40-42°C +/- 2°C for 15 minutes, showing the Sunny device meets similar therapeutic temperature ranges, albeit for a slightly shorter duration. |
| Energy Output levels for 1MHz and 2MHz | 10 levels, specifically: Level 1 (1MHz: 15.2W, 2MHz: 7.6W), Level 10 (1MHz: 40.5W, 2MHz: 20.2W). |
| Power Density (60 J/cm² for Pulsar) | "Similar" to predicate's 45.6 J/cm². |
| Safety & Compliance | |
| Electrical Safety | Compliance with IEC 60601-1:2005 + A2:2020. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 + A1:2020 and IEC TR 60601-4-2 Edition 1.0 2016-05. |
| High-Frequency Surgical Equipment Specific Requirements | Compliance with IEC 60601-2-2:2017 + A1:2023. |
| Software Life Cycle Processes | Compliance with IEC 62304:2006+A1:2015. Software verification and validation testing conducted per FDA guidance. |
| Risk Management | Compliance with EN ISO 14971:2019. |
| Biocompatibility | Materials contacting intact patient skin (<24 hours) determined to be biocompatible through testing. Compliance with ISO 10993-1:2018. |
| Accuracy of RF energy | Bench testing performed to verify accuracy. |
| Predicate Equivalence (Sunny RF Handpiece) | Demonstrated equivalence to Thermage CPT in general design, frequency (6.78 MHz), and intended use for electrocoagulation and hemostasis, supported by thermal testing. |
| Predicate Equivalence (Pulsar Handpiece) | Demonstrated equivalence in intended use, mechanism of action, and general design to the predicate device, supported by tissue temperature maintenance testing despite differences in output power and frequency. Also heavily references Nuera Tight RF (K210867) as a reference device sharing frequencies and specific indications. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for bench tests (RF accuracy, temperature maintenance, histopathology). For biological evaluation (biocompatibility), it typically involves testing material samples, not patient data in the context of device performance.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. The testing appears to be primarily bench testing and materials testing, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the provided document describes a hardware medical device (electrosurgical unit) and not an AI/software diagnostic tool. The "ground truth" for this device's performance is established through physical measurements, electrical output verification, thermal effect demonstration, and adherence to international safety and performance standards. Histopathology for thermal effect assessment would involve trained pathologists, but the number and qualifications are not specified nor is it a "ground truth" in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of discrepancies in human expert labels for AI ground truth, which is not relevant here. The testing methods described are standard engineering and safety compliance tests.
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
- Not applicable. The device is an energy-based surgical tool, not an AI diagnostic aid. No MRMC study involving human readers assisting with AI was performed or is relevant to its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to AI algorithm performance. The device performs its intended function autonomously based on user input (setting power, mode), and its performance is evaluated by its physical effects (e.g., thermal effect, temperature maintenance), not as an algorithm generating diagnostic outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is established primarily by:
- Bench Testing Measurements: Direct measurement of electrical parameters (power, frequency, energy output).
- Histopathology: Microscopic examination of tissue after device application to demonstrate thermal effects (for electrocoagulation/hemostasis). This is a form of pathology.
- Temperature Measurement: Direct measurement of skin temperature during operation to confirm therapeutic heating.
- Compliance with Standards: Meeting the requirements and specifications outlined in various IEC and ISO standards (e.g., 60601-1 for basic safety, 14971 for risk management, 10993-1 for biocompatibility).
8. The sample size for the training set
- Not applicable. The device is a hardware product, not a machine learning model. There is no "training set" in the context of AI. Design and development follow engineering principles, not data-driven model training.
9. How the ground truth for the training set was established
- Not applicable. Refer to point 8.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| ApplicantAddress | ShenB Co., Ltd.SHENB Tower, 74, Achasan-ro, Seongdong-gu, Seoul, Korea,Republic of |
|---|---|
| Contact Person | Aubrey Thompson, Regulatory Consultant |
| Contact Information | aubreythompson@hoyregulatory.com |
| Preparation Date | March 17, 2025 |
| Device Trade NameK NumberClassification NameRegulation NumberProduct CodeRegulatory Class | SunnyTMK242241Electrosurgical Cutting and Coagulation Device and Accessories878.4400GEI, PBXII |
| Legally Marketed Predicate DeviceReference Device | Thermage CPT (K173759)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.The subject device has the same indications for use as the reference device. |
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| 510(K) SummarySunny™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: MonopolarRadiofrequency | Monopolar Radiofrequency withvibration | Same. |
| Frequency | Sunny Handpiece: 6.78 MHz | 6.78 MHz | Same. |
| Max power | Sunny Handpiece:120 W | 400 W | Different. Thermal Effects testingdemonstrates effectiveness of the Sunnydevice at lower max power and desirableclinical effects from both devices as clinicallyrelevant 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 subjectdevice. | |
| Electrode size | 2.25 cm2 | 0.25 cm2, 3.0 cm2, and 16.0 cm2 | The treatment area of the predicate device isslightly larger than the subject. Other tips areincluded with the Thermage that are notincluded with the Sunny. |
| Pulse width | 1140ms | 100-2000 pulses delivered duringtreatment (length of pulse isunknown) | Different, but overall energy output range isnearly the same. |
| Power Density | 53.3 J/cm² | 45.6J/cm² | Similar. The slight difference in electrode sizecreates the difference in power density, butthe overall output energy range is verysimilar. |
| Energy Levels | 16 power levelsLevel 0.5 = 20W @400Ω rated loadLevel 8.0 = 120W @400Ω rated load | 19 power levels | similar |
| Duty Cycle | 81.4%, intermittent Use | 50%, intermittent Use | Different. Overall energy output range isnearly the same and the difference does notintroduce any safety issues. |
| Operatingmodes | Soft mode- gradually increased powerduring a single pulseHard mode – full power delivered (atselected level) during a single pulse | N/A | Different. Predicate device does not have asoft mode function. This does not impactsafety or effectiveness, it is only intended toincrease patient comfort. |
| Sterilization | Electrode tips are single use, notprovided sterile | Electrode tips are reusable, notprovided sterile | Neither device utilizes sterile tips, but thepredicate device requires pre-use cleaning. |
| Biocompatibility | Materials contact intact patient skinwith a contact duration of under 24 | Materials contact intact patientskin with a contact duration of | Same. |
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| hours. Materials have beendetermined to be biocompatiblethrough testing. | under 24 hours. Materials havebeen determined to bebiocompatible. |
|---|---|
| ---------------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
| Pulsar Handpiece Technical Specifications Comparison | ||||
|---|---|---|---|---|
| Sunny Device, PulsarHandpiece | Thermage CPT (PredicateDevice) | Nuera Tight RF(Reference Device) | Comparison | |
| Energy Delivery | Monopolar and BipolarRadiofrequency | MonopolarRadiofrequency withvibration | Monopolar and BipolarRadiofrequency | The subject and predicatedevices containmonopolar functionality.The Sunny Device alsocontains bipolarfunctionality. This doesnot impact the safety andefficacy of the device.The subject and referencedevices both havemonopolar and bipolarfunctionality. |
| Frequency | 1MHz, 2MHz | 6.78MHz | 470 kHz; 1 MHz; 2 MHz; 4MHz; 6 MHz | Different. Tissuetemperature testingdemonstrates that thedevices can performequivalently.The subject devices sharethe 1Mhz and 2MHzfrequencies with thereference device. |
| Max power | 40.5W at 1MHz | 400W (treatment is | 250W | Max power is higher with |
| 20.2W at 2MHz | recommended at lowerpower) | the predicate device.However, Thermagelabeling recommendsusing a lower power toensure patient comfort.Side by side testing wasconducted at power levelsthat were similar for thetwo devices anddemonstrates comparableperformance. | ||
| Pulse Width | 100 msec ~ 800 msec ±10% | Unknown | Unknown | The exact pulse width ofthe predicate is unknown,but the output energy isvery similar between thedevices. |
| Sterilization | Not sterile | Not sterile | One handpiece is sterile(ETO), other handpiecesare not provided sterile | Same |
| Patient ContactingMaterials | Intact skin contacting<24 hoursDeterminedbiocompatible throughtesting | Intact skin contacting<24 hoursDeterminedbiocompatible | Intact skin contacting<24 hoursDeterminedbiocompatible | Same |
| Performance goals | Temporary pain relief andincreased circulationthrough topical heating.Maintenance oftherapeutic temperature(40-43°C) for 10 mins oftreatment. | Temporary pain relief andincreased circulationthrough topical heating. | Temporary pain relief andincreased circulationthrough topical heating.Maintenance oftherapeutic temperature(40-42°C +/- 2°C) for 15mins of treatment. | Testing performance goalsare the same for thesubject and referencedevices. Subject andPredicate devices sharethe same indications foruse and performancetesting demonstrates thepredicate device canperform the same when |
| subjected to the sametest methods as the Sunnydevice. | ||||
| Energy levels | 10 levelsLevel 1:1MHz: 15.2 W @ 200 Ω2 MHz: 7.6W @200 ΩLevel 10:1 MHz: 40.5W @200 Ω2 MHz: 20.2W @200 Ω | 19 levels | The exact energy used atvarious levels for thepredicate is not known. | |
| Power density (totalpower per unit of area) | 60 J/cm² | 45.6J/cm² | Similar. | |
| Tip configuration (pinspacing penetration,power each pin) | Blazar Cartidge: Flat,Square electrodes2.25 cm²Quasar Cartridge: squareelectrodes with raisedindividual electrode pins,25 or 36 pins,corresponding to1.62 W/Pin or1.13 W/Pin.Electrode size: 2.33cm2 | Flat square electrodes,0.25 cm2, 3.0 cm2, and16.0 cm2 | 3.15cm², 7cm², 12.5cm²,28.25cm², 38.5cm²,78.5cm2 | The 2.25 cm electrode issimilar to the 3.0 cmelectrode of the predicatedevice. The different sizesavailable with theThermage are notavailable with the Sunny.The subject and referencedevice have slightlydifferent designs. Thereference deviceelectrodes are circularand all flat. The smallestelectrode of the referencedevice is similar in size tothe Pulsar electrodes. |
| Operational modespulse/continuous pulsecycles | Pulsed | Pulsed | Continuous | Same as predicate. |
| Treatment duration | 10 minutes | unknown | 15 minutes | Similar to reference device. |
| polarity | Monopolar, bipolar,combination ofmonopolar and bipolarityat varying ratios | Monopolar | Monopolar and bipolarelectrodes | Both devices includemonopolar functionality.The predicate device doesnot contain bipolarfunctionality. The bipolarfunction of the Sunnydevice is intended toprovide flexibility intreatment options for thepractitioner and does notimpact the safety oreffectiveness 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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.