Plasonic (Plasonic)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 8, 2024 Hironic Co., Ltd. Gwijin Lee Assistant Manager 19F, U-TOWER, 767, Sinsu-ro, Suji-gu Yongin-si, Gyeonggi-do 16827 Korea, South Re: K241099 Trade/Device Name: Plasonic (Plasonic) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, IMI Dated: October 11, 2024 Received: October 11, 2024 Dear Gwijin Lee: 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/cdrb/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" {1}------------------------------------------------ (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 820.30 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 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 Rule"). The UDI Rule requires, among other things, that a 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-advicecomprehensive-regulatory-assistance/unique-device-identification-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-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-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). {2}------------------------------------------------ Sincerely, Image /page/2/Picture/3 description: The image shows the name "Long H. Chen - S" in a large, clear font. To the right of the name, there is a statement indicating that the name was digitally signed by Long H. Chen - S. The date of the signature is provided as 2024.11.08 at 07:34:22, with a time zone offset of -05'00'. 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K241099 Device Name PLASONIC (PLASONIC) ### Indications for Use (Describe) The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue. The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. 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. 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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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for HIRONIC. The logo consists of a red square with a white arrow pointing to the right, followed by the word "HIRONIC" in black, block letters. The logo is simple and modern, and the colors are eye-catching. ### 510(k) Summary This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. 1. Submitter Information - 807.92(a)(1) | Applicant | Hironic Co., Ltd. | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do,<br>16827, Republic of Korea | | Phone Number | +82-31-525-7000 | | Fax Number | +82-31-525-7010 | | Contact Person | Gwijin Lee | | Contact Information | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do,<br>16827, Republic of Korea<br>t. +82-31-525-7000, m. +82-10-5049-2959, e. ra@hironic.com | | Preparation Date | Oct. 11th, 2024 | Date 510(k) summary prepared: Oct. 11th, 2024 | Trade/Device Name | PLASONIC | |---------------------|----------------------------------------------------------------| | Common Name | Electrosurgical System | | Classification Name | Electrosurgical cutting and coagulation device and accessories | | Product Code | GEI, IMI | | Regulation Number | 21 CFR 878.4400 | | Regulatory Class | II | | Review Panel | General & Plastic Surgery (ODE) | ### 2. Device Name and Code - 807.92(a)(2) 3. Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3) | Predicate Device - 1 | K223222<br>Applicant: Neauvia North America, Inc<br>Trade/Device Name: Plasma IQ<br>Regulation Number: 21 CFR 878.4400<br>Regulation Name: Electrosurgical Cutting and Coagulation Device<br>and Accessories<br>Regulatory Class: Class II<br>Product Code: GEI | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device - 2 | K230472<br>Applicant: Enraf-Nonius, B.V.<br>Trade/Device Name: Sonopuls 190<br>Regulation Number: 21 CFR 890.5300<br>Regulation Name: Ultrasonic Diathermy<br>Regulatory Class: Class II<br>Product Code: IMI | | Predicate Device - 3 | K161628<br>Applicant: Bonutti Research, Inc.<br>Trade/Device Name: JAS Pulse™ Ultrasonic Therapy<br>Regulation Number: 21 CFR 890.5300<br>Regulation Name: Ultrasonic Diathermy<br>Regulatory Class: Class II<br>Product Code: IMI | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "HIRONIC" in a stylized font. The first letter, "H", is red and has a unique design with a square and an arrow-like shape. The rest of the letters, "IRONIC", are in black and have a rounded, sans-serif appearance. The logo is simple and modern. ### 4. Device Description - 807.92(a)(4) The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable. The PLASONIC has two systems (two handpieces) : - 1) Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure. - 2) Ultrasound (SONOPASS Handpiece) The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being 5. Indication for Use - 807.92(a)(5) 1) Radiofrequency (Handpiece - PLAPASS) - Used in the removal and destruction of skin lesions and coagulation of tissue. 2) Ultrasound (Handpiece - SONOPASS) - Indicated for Pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. 6. Summary of the Technological Characteristics of the Device Compared to the Predicate - 807.92(a)(6) | Characteristics | Proposed Device | Predicate Device - 1 | Comparison<br>Comment | |-------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------| | 510(k) Number | Pending K241099 | K223222 | - | | Manufacturer | Hironic Co., Ltd. | Neauvia North<br>America, Inc | - | | Trade/Device Name | PLASONIC | Plasma IQ | - | | Product Code<br>(Regulation Number) | GEI (878.4400),<br>IMI (890.5300) | GEI (878.4400) | - | | Indication for use | Used in the<br>removal and<br>destruction of skin<br>lesions and<br>coagulation of<br>tissue. | Used in the removal<br>and destruction of<br>skin lesions and<br>coagulation of tissue. | Identical | | Mode of Operation | Radio Frequency<br>(Plasma) | Radio Frequency<br>(Plasma) | Identical | | Output | Monopolar | Monopolar | Identical | | Power Supply | 100-240VAC,<br>50/60Hz | 110-250VAC,<br>50/60Hz | Similar | | Frequency | 41kHz | 40kHz | Similar | - 1) Predicate Device 1 {6}------------------------------------------------ ## аніяОпіс | Max Output Power | 0.35W | 5W | Different, but the<br>safety of the product<br>has been proven by<br>the Safety Standard<br>Test Report, its<br>performance has<br>been proven by the<br>Performance Test<br>Report, and its<br>effectiveness for its<br>intended use has<br>been proven by the<br>Animal Test Report. | |--------------------------------|------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Output Impedance | $500 \Omega$ | $54,000 \Omega$ | Different, but the<br>safety of the product<br>has been proven by<br>the Safety Standard<br>Test Report, its<br>performance has<br>been proven by the<br>Performance Test<br>Report, and its<br>effectiveness for its<br>intended use has<br>been proven by the<br>Animal Test Report. | | Electrical Safety<br>Standards | Complies with IEC<br>60601-1, IEC<br>60601-1-2, IEC<br>60601-2-2 | Complies with EN<br>60601-1, EN 60601-<br>1-2, EN 60601-2-2 | Identical | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "HIRONIC" in a stylized font. The letters are black, except for a red square to the left of the word. The square has a white shape inside it. ### 2) Predicate Device – 2, 3 | Characteristics | Proposed Device | Predicate Device - 2 | Predicate Device - 3 | Comparison Comment | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Pending K241099 | K230472 | K161628 | | | Manufacturer | Hironic Co., Ltd. | Enraf-Nonius, B.V. | Bonutti Research, Inc. | | | Trade/Device Name | PLASONIC | Sonopuls 190 | JAS Pulse™ Ultrasonic<br>Therapy | | | Product Code<br>(Regulation Number) | GEI (878.4400),<br>IMI (890.5300) | IMI (890.5300) | IMI (890.5300) | | | Indications for Use | Indicated for Pain relief,<br>reduction of muscle<br>spasms, localized increase<br>in blood flow, increase<br>range of motion of<br>contracted jointed using<br>heat and stretch techniques | Indicated for pain relief,<br>reduction of muscle<br>spasms, localized increase<br>in blood flow, increase<br>range of motion of<br>contracted jointed using<br>heat and stretch techniques | Application of therapeutic<br>ultrasound for:<br>Pain.<br>Pain relief, muscle<br>spasms, and joint<br>contractures.<br>Relief of pain, muscle<br>spasms, and joint<br>contractures that may be<br>associated with:<br>o Adhesive capsulitis,<br>o Bursitis with slight<br>calcification,<br>o Myositis,<br>o Soft tissue injuries,<br>and<br>o Shortened tendons due to<br>past injuries and scar<br>tissues.<br>Relief of pain, muscle<br>spasms, and joint<br>contractures resulting<br>from:<br>o Capsular tightness,<br>and<br>o Capsular scarring | Identical to Predicate device<br>- 2.<br>Identical to Predicate device<br>- 3.<br>Pain relief, muscle<br>spasms, and joint<br>contractures<br>Localized increase in<br>blood flow.<br>Increased range of<br>motion of contracted joints<br>using heat and stretch<br>techniques. | | | | | Localized increase in<br>blood flow.<br>Increased range of<br>motion of contracted joints<br>using heat and stretch<br>techniques. | | | Weight<br>(Console & Treatment head) | 8.1 kg | 7 lbs 2oz | 0.151 kg<br>(with transducer) | Different, but does not<br>adversely affect safety and<br>effectiveness of the<br>proposed device. | | Dimension<br>(W x H x D) | 410.8 x 214 x 418.4 mm | 6.25 x 5.5 x 8" | 10.5 x 6.7 x 2.5cm | Different, but does not<br>adversely affect safety and<br>effectiveness of the<br>proposed device. | | Power Supply | 100-240VAC, 50/60Hz | 100-240 VAC +/- 10% | AC Line 100-240V 50/60 Hz | Identical. | | Patient Leakage Current | 1 $ μ $ A typical<br>(requirements IEC < 10 $ μ $ A) | 1 $ μ $ A typical<br>(requirements IEC < 10 $ μ $ A) | - Normal Condition<br>3uA<br>Meets IEC 60601-1, section<br>8.7<br>LEAKAGE CURRENTS<br>and<br>PATIENT AUXILIARY<br>CURRENTS<br><br>- Single Fault condition<br>5uA<br>Meets IEC 60601-1, section<br>8.7<br>LEAKAGE CURRENTS<br>and<br>PATIENT AUXILIARY<br>CURRENTS | Identical to Predicate device<br>- 2.<br><br>Different to Predicate device<br>- 3, but does not adversely<br>affect safety and<br>effectiveness of the<br>proposed device. | | Crystal material | PZT | PZT-8 (lead zirconate<br>titanate) piezoceramic<br>material | PZT | Identical. | | Housing Materials and<br>Construction | ABS | ABS | ABS | Identical. | | | | | | | | Technology of ultrasound<br>generation | Piezoelectric | Piezoelectric | Piezoelectric | Identical. | | Treatment Modes | Continuous<br>Pulsed | Continuous<br>Pulsed | Pulsed & Continuous | Identical. | | Beam Type<br>(collimated or divergent) | Divergent | 5 cm2 applicator:<br>1 MHz: collimating<br>3 MHz: collimating<br><br>0.8 cm2 applicator:<br>1 MHz: collimating<br>3 MHz: diverging | Collimated | Similar to Predicate device<br>- 2.<br><br>Different to Predicate device<br>- 3, but does not adversely<br>affect safety and<br>effectiveness of the<br>proposed device. | | Transducer Diameter (cm) | 2.5cm² | 0.8 cm²<br>5cm² | Diameter: 2.56 cm<br>Area: 5.15 cm² | Different to each device but<br>does not adversely impact<br>safety and effectiveness of<br>the proposed device. | | Frequency | 3MHz | 1MHz<br>3MHz | 1MHz | Similar to Predicate device<br>- 2.<br><br>Different to Predicate device<br>- 3, but does not adversely<br>affect safety and<br>effectiveness of the<br>proposed device. | | Acoustic Working<br>Frequency and Accuracy<br>(MHz) | 3MHz± 10% | 5 cm², 0.8 cm² and<br>1 MHz: 0.98 MHz ± 5%<br>3 MHz: 3.1 MHz ± 5% | 1.0 MHz ± 10% | Similar to Predicate device<br>- 2.<br><br>Different to Predicate device<br>- 3, but does not adversely<br>affect safety and<br>effectiveness of the<br>proposed device. | | Effective Radiating Area | 1.485 cm² | 5 cm² applicator:<br>5 cm² | 1.133 cm2 ± 20% | Similar to Predicate device -<br>3. | | | | 0.8 cm² applicator:<br>0.8 cm² | | | | Beam Non-uniformity Ratio | 3.9367:1 maximum | 6:1 maximum | 2.5 ± 30% | Different, but does not<br>adversely impact safety and<br>effectiveness of the<br>proposed device and<br>complies with IEC 60601-2-<br>5. | | Output Mode of Ultrasound<br>Head | Continuous mode: 1<br>Pulsed Mode: 4 | 2 | 2 | Similar to each device. | | Maximum Timer Setting | 10 minutes | 10 minutes | 15 minutes | Identical to Predicate device<br>- 2. | | Output power<br>(Intensity) | 0 - 0.18W/cm² | 0 - 3.0W/cm² | Continuous (High): 1.4 W/<br>cm2<br>Pulsed (Low): 0.7 W/ cm2<br>(all values ± 20%) | Different but does not<br>adversely impact safety and<br>effectiveness of the<br>proposed device and<br>complies with IEC 60601-2-<br>5. | | Pulse Frequency | 2Hz± 10% | 16Hz, 48Hz, 100Hz +/- 1% | - | Different to each device, but<br>does not adversely affect<br>safety and effectiveness of<br>the proposed device. | | Temporal Max Power (W) -<br>[for pulsed] | Duty cycle 25%: 0.12W<br>Duty cycle 50%: 0.14W<br>Duty cycle 62.5%: 0.21W<br>Duty cycle 75%: 0.20W | 5 cm² applicator:<br>duty cycle 5-50%: 15W<br>duty cycle 80%: 12W<br>0.8 cm² applicator:<br>duty cycle 5-50% 2.4 W<br>duty cycle 80%: 2 W | 0.79W | Different to each device but<br>does not adversely impact<br>safety and effectiveness of<br>the proposed device and<br>complies with IEC 60601-2-<br>5. | | Temporal Max Power (W) -<br>[for continuous] | 0.21W | 5 cm² applicator: 10 W<br>0.8 cm² applicator: 1.6 W | 1.59W | Different but does not<br>adversely impact safety and<br>effectiveness of the<br>proposed device and<br>complies with IEC 60601-2-<br>5. | | Maximum Value of the<br>Output Power (Rated<br>Output Power) and<br>Accuracy (W) | $0.21W \pm 20%$ | 5 cm² applicator: $10 W \pm$<br>20%<br>0.8 cm² applicator: $2 W \pm$<br>20% | Continuous (High): 1.59W<br>Pulsed (Low): 0.79W<br>(all values $\pm$ 20%) | Different but does not<br>adversely impact safety and<br>effectiveness of the<br>proposed device and<br>complies with IEC 60601-2-<br>5. | | Peak Temperature Rise<br>vs. Time and Tissue Depth<br>to Maximum Treatment<br>Time (for fixed Treatment<br>Head Placement) (deg C) | Elevation of temperature<br>raise 10.5 °C for 10<br>minutes 3.0 MHz, 0.21 W<br>Effective depth 0.5 cm | Elevation of temperature<br>raise 4.8°C for 10 minutes<br>1.0MHz, 2.0W Effective<br>depth 2.5cm<br>Elevation of temperature<br>raise 5.8°C for 3 minutes<br>3.0MHz, 2.0W Effective<br>depth 0.8cm | | Different to each device, but<br>does not adversely affect<br>safety and effectiveness of<br>the proposed device. | | Maximum Patient Contact<br>Surface Temperature of<br>Treatment Head under<br>Simulated fixed Treatment<br>Head Placement) (degC) or<br>Actual Use Conditions for all<br>Operating Conditions | 1.485 cm² applicator < 45<br>deg C | 5 cm² applicator <43 deg C<br>0.8 cm² applicator <34 deg<br>C | Transducer surface does<br>not exceed 43 °C when<br>measured under test<br>conditions 201.11.1.3.101.1<br>as stated in IEC 60601-2-5. | Different to each device, but<br>does not adversely affect<br>safety and effectiveness of<br>the proposed device. | | (Continually operated for<br>maximum treatment time)<br>(deg C) | | | | | | Penetration Depth | 3 MHz: 1.1 cm | 1MHz: 2.5cm<br>3MHz: 0.8cm | | Similar to Predicate device -<br>2. | | Electrical Safety Standards | Complies with IEC 60601-1,<br>IEC 60601-1-2, IEC60601-<br>2-5 | Complies with IEC 60601-1,<br>IEC 60601-1-2, IEC 60601-<br>2-5 | Complies with IEC 60601-1,<br>IEC 60601-1-2, IEC 60601-<br>2-5 | Identical. | {8}------------------------------------------------ ## аніяопіс {9}------------------------------------------------ ## аніяопіс {10}------------------------------------------------ # анікопіс {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for HIRONIC. The logo consists of a red square with a white shape inside, followed by the word "HIRONIC" in black, block letters. The letters are stylized and have a modern look. {12}------------------------------------------------ # аніяопіс {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the word "HIRONIC" in a bold, sans-serif font. The letters are black, except for a red square-like shape to the left of the word. The red shape has a white, stylized "H" inside it. 7. Non-clinical tests submitted - 807.92(b)(1) - IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance - IEC 60601-2-2:2017/AMD1:2023 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 60601-2-5:2009 for use with IEC 60601-1:2005. COR1:2006 COR2:2007. AMD1:2012 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment: - 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 is evaluated in accordance with the FDA-recognized consensus standard - IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability is evaluated in accordance with the FDA-recognized consensus standard - IEC 62304:2006 Medical device software Software life cycle processes is evaluated according to the FDA-recognized consensus standard - IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices is evaluated in accordance with the FDA-recognized consensus standard - ISO 14971:2019 Medical devices Application of risk management to medical devices - In the ex vivo model, the handpieces were applied in the same way as applied to the actual human body and the temperature change of the application site was analyzed through a thermal imaging camera. In addition, the length, width and depth of tissue coagulation at the application site were analyzed through photography and histological evaluation. ### 8. Clinical tests submitted - 807.92(b)(2) No clinical test was performed. 9. Conclusions drawn from clinical and non-clinical tests submitted The PLASONIC is substantially equivalent to its predicate device and reference device with same indication for use and technological characteristics. The non-clinical data for proposed device, including biocompatibility, bench testing, hardware and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety test shows that the device is safe to use and meets required standards. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device.