The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).
It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

Device Description

Pollogen Ltd's modified Legend*™ system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:

Main Unit (includes the Controller); -
Control Panel (User Interface); -
RF Generator; -
VO (VoluDerm) Treatment Applicator -
Disposable tips; gen12, gen36 & gen36L -
Treatment Applicators 1-3 (TriPollar); -
Foot Switch; -
Patient-Controlled Manual Switch. -
The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.
The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

AI/ML Overview

The provided text describes Pollogen Ltd.'s modified Legend+™ System, an electrosurgical cutting and coagulation device. The key focus of the submission for K173503 is to add a new disposable tip, gen36L, to the existing VO applicator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of quantitative performance metrics for the device's efficacy in ablation, resurfacing, or wrinkle treatment. Instead, the acceptance criteria appear to be framed around demonstrating substantial equivalence to a predicate device (Pollogen Legend+™ System K171359) and establishing safety and effectiveness, particularly for the new gen36L tip.

The performance data primarily focuses on compliance with international standards and a pre-clinical animal study.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness (for gen36L tip)	Animal Study: Tested on 3 pigs. No procedure-related complications or premature deaths. Macroscopic and histological evaluations demonstrated the device can safely perform ablation and resurfacing of the skin.
Compliance with Electrical Safety Standards	Performance Tests: Demonstrated compliance with: - IEC/EN 60601-1 Ed 3.1 (Medical Electrical Equipment Part 1: General requirements for safety)- IEC/EN 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and accessories, including emission & immunity)- IEC 62304 (Medical device software Software life cycle processes)
Biocompatibility	Performance Test: All parts in contact with the patient comply with the requirements of ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing) and ISO 10993-7 (Ethylene oxide sterilization residuals).
Software Verification and Validation	Performance Test: Software verified and validated according to FDA guidance.
Substantial Equivalence (Intended Use)	The modified Legend+™ system has the same intended use and indications for use as the predicate device, including ablation and resurfacing of skin with VoluDerm Energy (VO applicator) and non-invasive treatment of mild to moderate facial wrinkles and rhytides with TriPollar RF Energy.
Substantial Equivalence (Technological Characteristics)	Similar technological characteristics to the predicate device. The only difference is the addition of the gen36L tip. The minor difference in electrode pin length of gen36L (1000 microns vs. 600 microns for gen12/gen36) is deemed not to raise new safety/effectiveness questions, supported by comparison to a reference device (INTRAcel Premium K153727) which has similar or longer pins.
Substantial Equivalence (Principles of Operation)	The principles of operation (bipolar RF energy delivery, fractional non-homogeneous delivery via multi-electrode pins for VO, and homogenous heating for TriPollar for collagen remodeling) are the same as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Animal Study: 3 pigs.
- Data Provenance: Not explicitly stated, but implies a controlled laboratory setting given "animal study." The manufacturer is Pollogen Ltd. in Israel, suggesting the study was likely conducted or overseen in that region or a designated test facility. This is a prospective study for the purpose of demonstrating the safety and effectiveness of the new tip.
For other performance tests (standards compliance, biocompatibility, software V&V): The document does not specify sample sizes, as these are typically validated through engineering tests, documentation reviews, and adherence to established protocols rather than case-based test sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Animal Study: The document states "macroscopic and histological evaluation of the tissue." This implies that veterinary pathologists or other qualified experts conducted these evaluations. However, the exact number of experts and their specific qualifications (e.g., years of experience, board certifications) are not specified in the provided text.

4. Adjudication Method for the Test Set

Animal Study: The document does not explicitly state an adjudication method (like 2+1, 3+1, etc.) for the macroscopic and histological evaluations. It simply mentions that these evaluations were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was NOT done. The study's purpose was to demonstrate the safety and effectiveness of a device modification (the gen36L tip) by showing substantial equivalence to an already cleared predicate, rather than to compare human reader performance with and without AI assistance. The device in question is a medical device for skin treatment, not an AI or imaging diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done

Not applicable in the context of typical AI/diagnostic standalone studies. The Pollogen Legend+™ System is a hardware device delivering RF energy, operated by a human. Its performance is inherent to its physical operation, not an algorithm interpreted by itself. The software verification and validation are for the operational integrity of the device's control system, not for an AI diagnostic algorithm operating standalone.

7. The Type of Ground Truth Used

Animal Study: The ground truth for the animal study was established through histological evaluation of tissue samples from the treated areas. This is a definitive biological assessment of tissue changes at a microscopic level. It also mentions "macroscopic evaluation," which represents visual assessment.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model that requires a training set of data. The "training" for the device would involve engineering design, component testing, and calibration.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, this is not an AI model requiring a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

June 11, 2018

Pollogen Ltd. % Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Had Nes, 1295000 Israel

Re: K173503

Trade/Device Name: Pollogen Legend System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 8, 2018 Received: April 11, 2018

Dear Elissa Burg:

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 (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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Section 6 - Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K173503
Device Name	Pollogen Legend+™ System
Indications for Use (Describe)	The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

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)
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
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Section 7 - 510(k) Summary

Pollogen Ltd's Legend+™ System

Applicant's name:	Pollogen Ltd.
	6 Kaufman St.
	Gibor House, P.O.B. 50320
	Tel Aviv
	ISRAEL 6801298
	Tel. (972)3-510-4110
	Fax (972)3-510-4112

Contact Person: Elissa Burg Regulatory Consultant BioVision Ltd. Had Nes 183 Israel 1295000 Tel. (972) 526633572 Fax (972) 4-6827312
Date Prepared: June 6, 2018
Pollogen Ltd's Legend+™ system Name of Device:

Common or Usual Name: Electrosurgical cutting and coagulation device and accessories

Classification: Product Code: GEI Regulation No: 21 C.F.R. §878.4400 Class: II Classification Panel: General & Plastic Surgery
Pollogen Legend+™ System (K171359) Predicate Device:
Reference Device: INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)

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Intended Use / Indications for Use

The Modified Legend*™ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).

Modified Device Description

Pollogen Ltd's modified Legend*"system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:

Main Unit (includes the Controller); -
Control Panel (User Interface); -
RF Generator; -
VO (VoluDerm) Treatment Applicator -
Disposable tips; gen12, gen36 & gen36L -
Treatment Applicators 1-3 (TriPollar); -
Foot Switch; -
Patient-Controlled Manual Switch. -

The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.

The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

Technological Characteristics

Pollogen's modified Legend*™ system has similar technological characteristics as the Pollogen Legendt" system that was previously cleared under K171359. The primary purpose of this

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submission is to add an optional disposable tip, gen36L, to the cleared Legend+"" System's VO applicator.

Pollogen Ltd's modified Legend+"system consists of a console, Applicators 1-3 (TriPollar) and VO (VoluDerm) hand held applicators, and disposable tips. It is designed to deliver bipolar radiofrequency electrical current to the skin.

Performance Data

Pollogen conducted several performance tests to demonstrate that the modified Legend™ system complies with the following standards and that it functions as intended.

IEC/EN 60601-1 Edition 3.1 Medical Electrical Equipment Part 1: General . requirements for safety (2005/AMD:2012).
IEC/EN 60601-2-2 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 (2009)
IEC 60601-1-2 Medical Electrical Equipment Part 2. Collateral standard: . Electromagnetic compatibility - Requirements and tests (2007, Ed. 3).
IEC 60601-2-2 Medical electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (2006); clauses 36.201 (Emission) & 36.202 (Immunity)
IEC 62304 Medical device software Software life cycle processes . (2006/AMD2015)
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: ● Evaluation and testing
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: ● Ethylene oxide sterilization residuals

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Animal Study

An animal study was conducted, 3 pigs underwent treatment for ablation and resurfacing of the skin with the modified Legend ""system while using the gen36L tip. There were no procedure related complications or premature deaths in this study, for all follow-up evaluation time points up to two weeks.

The safety and effectiveness of the modified Legend+"system was evaluated by macroscopic and histological evaluation of the tissue in the treatment areas. These studies demonstrated that the modified Legend*™system can safely perform ablation and resurfacing of the skin for dermatological procedures.

Substantial Equivalence

The following table compares the modified Legend+™system to the predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

	Subject Device:	Predicate Device:	Applicator Weight	A1- 0.78 KgA2- 0.66 KgA3- 0.6 KgVO- 0.47 Kg	A1- 0.78 KgA2- 0.66 KgA3- 0.6 KgVO- 0.47 Kg
	Modified Pollogen Ltd.Legend+™ system – Applicator VOand Applicators 1-3(K173503)	Pollogen Ltd.Legend+ system – Applicator VOand Applicators 1-3(K171359)	System Dimensions:h•w•d	110cm x 45cm x 45cm43.3" x 17.72" x 17.72"	110cm x 45cm x 45cm43.3" x 17.72" x 17.72"
Device Class	Class II	Class II	Number ofApplicators	4	4
Classification Panel	General and Plastic Surgery	General and Plastic Surgery	Applicator Type	VO: Fractional Bi Polar RFA1: Bi Polar RFA2: Bi Polar RFA3: Bi Polar RF	VO: Fractional Bi Polar RFA1: Bi Polar RFA2: Bi Polar RFA3: Bi Polar RF
Product Code	GEI	GEI	Comparison ofdisposable tips	gen 12, gen 36, gen 36L	gen 12, gen 36
RegulationDescription	Device, electrosurgical, cutting andcoagulation device and accessories.	Device, electrosurgical, cutting andcoagulation device and accessories.	Number of electrodepins	gen 12: 6x2gen 36: 6x6gen 36L: 6x6	gen 12: 6x2gen 36: 6x6
Regulation Number	21 C.F.R. §878.4400	21 C.F.R. §878.4400	The distance betweenthe electrode pins	gen 12: 2.2mmgen 36: 2.2mmgen 36L: 2.2mm	gen 12: 2.2mmgen 36: 2.2mm
Intended Use andclinical indication	The Modified Pollogen Legend+™system is intended for dermatologicalprocedures requiring ablation andresurfacing of the skin when usingVoluDerm Energy (Applicator VO).It is also intended for use indermatologic and general surgicalprocedures for the non-invasivetreatment of mild to moderate facialwrinkles and rhytides when usingTriPollar RF Energy (Applicators 1-3).	The Pollogen Legend+™ system isintended for dermatological proceduresrequiring ablation and resurfacing ofthe skin when using VoluDerm Energy(Applicator VO).It is also intended for use indermatologic and general surgicalprocedures for the non-invasivetreatment of mild to moderate facialwrinkles and rhytides when usingTriPollar RF Energy (Applicators 1-3).	Treatment area size	gen 12: 11x2.2mmgen 36: 11x11mmgen 36L: 11x11mm	gen 12: 11x2.2mmgen 36: 11x11mm
Device Description	The Modified Pollogen Legend+™ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and Patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area.	The Pollogen Legend+™ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and Patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area.	Electrode pin'sdiameter	gen 12: 150 micronsgen 36: 150 micronsgen 36L: 150 microns	gen 12: 150 micronsgen 36: 150 microns
Principles of Operation:	The Modified Pollogen Legend+™ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides.	The Pollogen Legend+™ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin. Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides.	Electrode pin'slength	gen 12: ~600 micronsgen 36: ~600 micronsgen 36L: ~1000 microns	gen 12: ~600 micronsgen 36: ~600 microns
Energy Source:	RF (Bipolar)	RF (Bipolar)	RF energy per pin	up to 62mJ/pin	up to 62mJ/pin
Frequency:	1 MHz	1 MHz	Maximum number ofpulses	800	800
Maximum Output Power	44 Watts on 300 ohm for VO applicator.	44 Watts on 300 ohm for VO applicator.	Modes of Operation(Treatmentprograms):	VO: Low, Medium, HighA1: A1-A; A1-BA2: A2-A; A2-BA3: A3-A; A3-B	VO: Low, Medium, HighA1: A1-A; A1-BA2: A2-A; A2-BA3: A3-A; A3-B
	50 Watts on 200 ohm for applicators no. 1 and no.2.15 Watts on 200 ohm for applicator no. 3.	50 Watts on 200 ohm for applicators no. 1 and no.2.15 Watts on 200 ohm for applicator no. 3.	Biocompatibility	All parts that are in contact withpatient comply with the requirementsof ISO 10993-1	All parts that are in contact with patientcomply with the requirements of ISO10993-1
Electrical Requirements	100-240 Volt, max 2.2A, 50- 60Hz	100-240 Volt, max 2.2A, 50-60Hz	Software	Verified and validated according tothe FDA guidance	Verified and validated according to theFDA guidance
System Weight	~30 Kgs/66.14 lb	~30 Kgs/66.14 lb

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Attachment 1 - Interactive Additional Information for K173503/S002

Pollogen Legend+™ System

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Pollogen's modified Legend*™ system has the same intended use and indications for use and similar technological characteristics and principles of operation as its predicate device. No technological differences exist between the modified Legend*" system and its predicate device, except for the addition of an optional disposable tip gen36L that can be used with the VO applicator.

The minor difference in the length of the electrode pins of the gen36L has been demonstrated via the reference predicate device, INTRAcel Premium (K153727), an RF energy device for electrocoagulation procedures that has the same or longer length pins and therefore, the minor increase in pin length does not raise new or different questions of safety or effectiveness. Furthermore, performance data and a pre-clinical study both demonstrate that the modified Legend+™ system is as safe and effective as its predicate device.

Thus, Pollogen's modified Legend™ system is substantially equivalent to its predicate device.

Regulation Number and Section

§ 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.