Plaxpot Multi Plasma

K220493 · Gcs Co. Limited · QVJ · Oct 27, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K220493
• Device Name: Plaxpot Multi Plasma
• Applicant: Gcs Co. Limited
• Product Code: QVJ · General, Plastic Surgery
• Decision Date: Oct 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

Device Story

Handheld electrosurgical device; utilizes high-frequency current to ionize air, creating plasma arc between electrode tip and skin; enables non-contact tissue sublimation and coagulation; powered by internal rechargeable lithium-ion battery; operated by clinician in clinical setting; device features OLED display and mode selection (0.7W, 1W, 2W); output is monopolar; provides precise tissue removal without heat transfer to surrounding areas; benefits patient through targeted lesion destruction.

Clinical Evidence

Bench testing only. Testing included basic safety and essential performance (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and thermal effects testing per FDA guidance for electrosurgical devices. All tests passed.

Technological Characteristics

Monopolar electrosurgical device; 70 kHz frequency; 3 power modes (0.7W, 1W, 2W); internal 7.4 VDC 1000mAh Li-ion battery; OLED display; non-sterile; reusable; complies with IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for the removal and destruction of skin lesions and coagulation of tissue in patients requiring electrosurgical treatment.

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

• SubNovii Advanced Plasma Technology (K201738)

Reference Devices

• Plasma IQ (K192813)

Submission Summary (Full Text)

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October 27, 2023

GCS Co. Limited % Su Kyung Park Director Compliance Insight 497 Circle Freeway Dr. Unit 230 West Chester, Ohio 45246

Re: K220493

Trade/Device Name: Plaxpot Multi Plasma Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: QVJ Dated: [NOTE: Use date of most recent supplement] Received: September 29, 2023

Dear Su Kyung Park:

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" (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).

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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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.27
> 16:19:00 -04'00' Mark Trumbore, 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) K220493

Device Name PLAXPOT™ MULTI PLASMA

Indications for Use (Describe) PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <div> <span>☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## PLAXPOT™ MULTI PLASMA

# 510(k) Summary

#### General Information 5.1

18 February 2022 Preparation Date:

26 October 2023 Revision Date:

## Submitter/Holder

Su Kyung, Park

Director

GCS Co., Ltd. #1008, 555, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea Tel: [phone] Fax : [phone] Email: kara21c(@gcsgroup.co.kr

Website: http://www.bestgcs.com/

## Primary Contact

Cynthia Ipach President/CEO

Email: [e-mail]

Office [phone] ext. 306 Compliance Insight 497 Circle Freeway Dr Suite 230. Cincinnati, OH 45246

#### 5.2 Regulatory Information

| Subject Device Trade Name | PLAXPOT TM MULTI PLASMA |
|---------------------------|-------------------------------------------------------------------|
| Classification Name | Low Power Electrosurgical Devices For Skin Lesion<br>Destruction |
| Device Classification | II |
| Regulation Description | Electrosurgical cutting and coagulation device and<br>accessories |
| FDA Product Code | QVJ |
| CFR References | 21 CFR 878.4400 |
| Review Panel | General & Plastic Surgery |

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#### 5.3 Identification of Predicate Devices

The primary predicate device for PLAXPOT™ MULTI PLASMA is the SubNovii Advanced Plasma Technology (K201738) and the reference device is Plasma IQ (K192813).

#### 5.4 Subject Device Description

PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue.

After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc.

This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.

#### ર્સ્ટ Indications for Use

PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

#### Substantial Equivalence Discussion 5.6

In Table 1 on the following page please find a characteristics comparison summary. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that PLAXPOT™ MULTI PLASMA is substantially equivalent to the primary predicate device, the SubNovii Advanced Plasma Technology K201738.

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| Device<br>Characteristics | Proposed<br>Device | Primary<br>Predicate | Reference<br>Device |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product Name | PLAXPOTTM<br>MULTI PLASMA | SubNovii<br>Advanced<br>Plasma<br>Technology | Plasma IQ |
| 510(k) | K220493 | K201738 | K192813 |
| Manufacturer | GCS Co. Ltd. | Cartessa<br>Aesthetics | Neauvia North<br>America |
| FDA Product<br>Code | QVJ | GEI | GEI |
| CFR Reference | 878.4400 | 878.4400 | 878.4400 |
| Device Class | II | II | II |
| Prescription or<br>OTC | Prescription | Prescription | Prescription |
| Implanted<br>Device | No | No | No |
| Indications for<br>Use Statement | PLAXPOT™<br>MULTI PLASMA<br>is intended for the<br>removal and<br>destruction of skin<br>lesions and<br>coagulation of<br>tissue. | The SubNovii is<br>intended for the<br>removal and<br>destruction of<br>skin lesions and<br>coagulation of<br>tissue. | Plasma IQ is<br>used in the<br>removal and<br>destruction of<br>skin lesions and<br>coagulation of<br>tissue. |
| Mode of<br>Operation | Plasma high<br>frequency current<br>ionizing the air<br>creating a plasma<br>stream. | Plasma<br>radiofrequency<br>energy ionizes<br>the air creating a<br>plasma stream. | Plasma<br>radiofrequency<br>energy ionizes<br>the air creating<br>a plasma<br>stream. |
| Output Mode | Continuous | Continuous | Continuous |
| Energy Type | High Frequency | High Frequency | High Frequency |
| Power Level | 3 modes at 0.7W,<br>1W, 2W | Max 5W | Max 5W |
| Reusable or<br>Single Use | Reusable | Reusable | Reusable |
| Output | Monopolar | Monopolar | Monopolar |
| Max Power<br>Output | 3W | 5W | 5W |
| Power Supply | Internal<br>Rechargeable<br>Lithium Ion<br>Battery 7.4 VDC<br>1000mAh | Internal<br>Rechargeable<br>Lithium Ion<br>Battery 11.1<br>VDC | Internal<br>Rechargeable<br>Lithium Ion<br>Battery 11.1<br>VDC |
| Frequency | 70 kHz | 40kHz | 40kHz |
| System<br>Components | A handpiece that<br>incorporates the<br>electrosurgical<br>generator unit,<br>OLED display,<br>software, and<br>docking station. | A handpiece that<br>incorporates the<br>electrosurgical<br>generator unit,<br>docking station<br>and an active<br>electrode. | A handpiece<br>that<br>incorporates the<br>electrosurgical<br>generator unit,<br>docking station<br>and an active<br>electrode. |
| Electrical<br>Safety<br>Standards | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 |
| Software | Yes | No | No |
| Software<br>Compliance | IEC 62304 | N/A | N/A |

# Table 1. Summary Comparison of Characteristics

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# PLAXPOT™ MULTI PLASMA

#### 5.7 Sterilization and Shelf Life

The PLAXPOT™ MULTI PLASMA is sold non-sterile.

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Shelf-life is not applicable because of low likelihood of time-dependent product degradation.

#### Performance Testing - Bench 5.8

Performance bench tests of PLAXPOT™ MULTI PLASMA have been performed, see Table 2. The results from the performance bench testing demonstrate that PLAXPOT™ MULTI PLASMA has met the functional requirements and is substantially equivalent to the predicate device. Performance bench testing is provided in detail.

| Study | Attachment | Test Method | Results |
|-------------------------------------------|------------|--------------------------------------------------------------------------------------------------|---------|
| Basic Safety and<br>Essential Performance | 18-3 | EN 60601-<br>1:2006+A1:2013 or EN<br>60601-<br>1:2006+A12:2014 and<br>test report<br>IEC60601_1K | Pass |
| Manufacturer<br>Technical File | 18-5 | N/A | Pass |
| EMC Test | 18-6 | IEC 60601-1-2:2014 | Pass |
| EMC Test | 18-7 | IEC 60601-1-2:2014 | Pass |
| Thermal Effects Test | NA | FDA Submissions for<br>Electrosurgical Devices<br>for General Surgery | Pass |

### Table 2. Performance Testing Summary

#### 5.9 Conclusion

The subject device PLAXPOT™ MULTI PLASMA has the same technology, principle of operation, indications for use and technical specifications as the primary predicate device Subnovii and the reference device Plasma IQ. PLAXPOT™ MULTI PLASMA shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) as the predicate device and no new elements pertaining to safety or effectiveness have been identified. Performance test results demonstrate that the subject device can perform the same intended use as safely as the predicate and reference devices. Therefore, the subject device is substantially equivalent to the predicate.