RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Device Description

RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

AI/ML Overview

The provided FDA 510(k) clearance letter for RFMagik Lite does not contain information about specific acceptance criteria or a study that directly proves the device meets such criteria in terms of clinical performance or effectiveness. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (electrical, EMC, biocompatibility, sterility, shelf life, and performance bench testing) and an ex vivo study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates, or comparative outcomes) are mentioned in the document for the RFMagik Lite. The "performance testing" referenced is primarily bench testing to ensure the device operates safely within design specifications. The acceptance criteria for the non-clinical tests are implicit in the adherence to recognized standards.

Acceptance Criteria Category	Specific Criteria (Implicit from standards)	Reported Device Performance (Implicit from successful testing)
Electrical Safety	Compliance with AAMI ES60601-1, IEC60601-2-2	Passed (stated that testing shows the device is safe)
EMC	Compliance with IEC 60601-1-2, TR IEC 60601-4-2	Passed (stated that testing shows the device is safe)
Biocompatibility	Compliance with ISO 10993 series	Passed (stated that non-clinical data shows the device should perform as intended)
Sterility	Compliance with ISO 11135, ISO 11138 series, ISO 10993-7	Verified and validated (EO gas sterilization)
Shelf Life	Compliance with ISO 11607 series, ASTM F1929, ASTM F88M	Passed (stated that non-clinical data shows the device should perform as intended)
Performance Testing	Operates safely and within predefined design specifications	Passed (stated that AGNES MEDICAL conducted bench testing to assure this)
Ex Vivo Study	Thermal testing consistent with FDA guidance	Conducted on liver, skin, and muscle under GLP conditions (no specific performance metrics given)

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

The document does not specify a "test set" in the context of clinical or human subject data. The testing mentioned is non-clinical (bench, ex vivo). For the ex vivo study, the number of tissue types used was three (liver, skin, and muscle), but the specific number of samples or specimens within each tissue type is not provided.

The provenance of this ex vivo data would be laboratory-based, focusing on tissue samples rather than human subjects. The country of origin for the ex vivo study is not explicitly stated, but the submission is from a South Korean company.

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

Since there is no mention of a clinical "test set" or human subject data, there is no information about experts establishing ground truth for such a set. The ex vivo study would likely involve experts in histology or pathology for evaluating thermal effects, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as there is no described clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The RFMagik Lite is an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The RFMagik Lite is a physical electrosurgical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the adherence to and successful completion of recognized consensus standards (e.g., AAMI ES60601-1, IEC60601-2-2 for electrical safety, ISO 10993 for biocompatibility). For the ex vivo study, the "ground truth" would likely be the observed thermal effects on the tested tissues, assessed against predetermined safety or efficacy thresholds (though these thresholds are not explicitly stated in the document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

FDA 510(k) Clearance Letter - RFMagik Lite

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov

April 25, 2025

Agnes Medical Co., Ltd
℅ Sanghwa Myung
Regulatory Affair Specialist
E&m
D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu
Anyangsi, Gyeonggi-do 14067
Korea, South

Re: K242469
Trade/Device Name: RFMagik Lite
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: March 27, 2025
Received: March 27, 2025

Dear Sanghwa Myung:

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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K242469 - Sanghwa Myung Page 2

(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 QS 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 (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-reporting-combination-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 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-devices/device-advice-comprehensive-regulatory-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K242469 - Sanghwa Myung Page 3

Sincerely,

James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.04.25 13:41:51 -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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K242469

Device Name: RFMagik Lite

Indications for Use (Describe):
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."

Page 5

510(k) Summary

K242469

This summary of 510(K) – safety and effectiveness information are being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter: AGNES MEDICAL CO., LTD.
(Seohyeon-Dong, 5f Cocoplaza), 20, Seohyeon-Ro 210beon-Gil, Bundang-Gu,
Seongnam-Si, Gyeonggido, Korea (ZIP code: 13591)
Telephone: +82-31-8020-9702
Fax: +82-31-701-5162
E-mail: phee3928@agnesmedical.com

Contact: E&M
Regulatory Affair/Terri Myung
Telephone: +82-70-7807-0550
FAX: +82-31-388-9263
Cellphone: +82-10-4952-6638
E-mail: mshenmc@gmail.com
Primary Contact: Terri Myung

Date 510(k) summary prepared: April 24th, 2025

1. Proposed Device Identification

Product Name: RF Electrosurgical Device
Trade Name (Model): RFMagik Lite
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number: 21 CFR 878.4400
Device Class: Class II
Product Code: GEI
Review Panel: General & Plastic Surgery

2. Primary Predicate Device Identification

Manufacturer: Jeisys Medical Inc.
510(k) Number: K231216
Device Name: POTENZA
Common Name: Electrosurgical cutting and coagulation device and accessories
Classification Name: Electrosurgical cutting and coagulation device and accessories
Classification Product Code and Regulation: GEI, 21CFR 878.4400
Device Class: II

3. Secondary predicate Device identification

510(k) Number: K223805
Device Name: AGNES

Page 6

Manufacturer: AGNES MEDICAL CO., LTD.
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number: 21 CFR 878.4400
Device Class: Class II
Product Code: GEI, KCW
Review Panel: General & Plastic Surgery

4. Device Description

5. Indication for use

RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

6. Summary of Technological Characteristics Comparison

The following comparison table is presented to demonstrate substantial equivalence.

Primary predicate device

	Subject device	Primary Predicate Device
Manufacturer	AGNES Medical Co., Ltd.	Jeisys Medical Inc
Device Name	RFMagik Lite	POTENZA
510(k) number	-	K231216
Classification Name	Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400)	Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400)
Product code	GEI	GEI
Indication for use	RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.	The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Mode of operation	Monopolar	Monopolar/Bipolar
Output energy	Radiofrequency	Radiofrequency
Output Frequency	1MHz	1MHz, 2 MHz
Rated Input	AC 100-240V, 50/60Hz	AC 100-240V, 50/60Hz
Output Power	Max. 32W	Max 50W

Page 7

	Subject device	Primary Predicate Device
Maximum Power Delivered to Patient	Up to 32W (200ohm)	Up to 50W (200ohm)
Impedance	200 ohm	200 ohm
Electrode Needles	RO-25S, RO-25D	- Ten different electrode tips for the motor handpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25TIP, S-16 TIP, and I-16TIP, C21-2 TIP, C21-1TIP, CP-21 TIP, and C9TIP- Three electrode needle tips for the AC handpiece: P1-08, A1-12, and A1-15- Three electrode tips for the motor handpiece: CP-16 TIP, CP-25 TIP and CP-49 TIP.
Electrode type	Micro needle type	Micro needle type
Electrode needle shelf life	3 years	3 years
Materials	Stainless Steel + No coating	Paracyclophane+STS304
Needle length	0.4mm, 1.2mm	0.5~2.5 mm
Needle thickness	0.2 mm	0.25 mm, 0.35mm
Needle amount	25ea	CP-49: 49eaCP-25: 25eaCP-16: 16ea
Treatment Area	RO-25S: 8.5mm ⨉ 9.3mmRO-25D: 8.5mm ⨉ 9.3mm	CP-49: 7.8mm ⨉ 7.8mmCP-25: 8.0mm ⨉ 8.0mmCP-16: 3.9mm ⨉ 3.9mm
Inter needle spacing	RO-25S, RO-25D: 2.0mm	CP-49: 1.3mmCP-25: 2.0mmCP-16: 1.3mm
Max insertion depth	1.2mm	2.5mm
Min insertion depth	0.4mm	0.5mm
Thickness of the needle	0.2mm	0.35mm

Secondary predicate Device

Descriptive Information	Subject Device	Secondary Predicate device
Manufacturer	AGNES MEDICAL CO., LTD	AGNES MEDICAL CO., LTD
Device Name	RFMagik Lite	AGNES
510(k) number	-	K223805
Primary Product Code / Regulatory Number	GEI / 878.4400	GEI / 878.4400
Secondary Product Code	N/A	KCW / 878.5350

Page 8

	Subject Device	Secondary Predicate device
Maximum Power Delivered to Patient	Up to 32W (200ohm)	Up to 50W (200ohm)
Impedance	200 ohm	200 ohm
Electrode Needles	RO-25S, RO-25D	- Ten different electrode tips for the motor handpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25TIP, S-16 TIP, and I-16TIP, C21-2 TIP, C21-1TIP, CP-21 TIP, and C9TIP- Three electrode needle tips for the AC handpiece: P1-08, A1-12, and A1-15- Three electrode tips for the motor handpiece: CP-16 TIP, CP-25 TIP and CP-49 TIP.
Electrode type	Micro needle type	Micro needle type
Electrode needle shelf-life	3 years	3 years
Materials	Stainless Steel + No coating	Paracyclophane+STS304
Needle length	0.4mm, 1.2mm	0.5~2.5 mm
Needle thickness	0.2 mm	0.25 mm, 0.35mm
Needle amount	25ea	CP-49: 49eaCP-25: 25eaCP-16: 16ea
Treatment Area	RO-25S: 8.5mm ⨉ 9.3mmRO-25D: 8.5mm ⨉ 9.3mm	CP-49: 7.8mm ⨉ 7.8mmCP-25: 8.0mm ⨉ 8.0mmCP-16: 3.9mm ⨉ 3.9mm
Inter needle spacing	RO-25S, RO-25D: 2.0mm	CP-49: 1.3mmCP-25: 2.0mmCP-16: 1.3mm
Max insertion depth	1.2mm	2.5mm
Min insertion depth	0.4mm	0.5mm
Thickness of the needle	0.2mm	0.35mm

Secondary predicate Device

Descriptive Information	Subject Device	Secondary Predicate device
Manufacturer	AGNES MEDICAL CO., LTD	AGNES MEDICAL CO., LTD
Device Name	RFMagik Lite	AGNES
510(k) number	-	K223805
Primary Product Code / Regulatory Number	GEI / 878.4400	GEI / 878.4400
Secondary Product Code	N/A	KCW / 878.5350

Page 9

	Subject Device	Secondary Predicate device
Regulatory Class	II	II
Indications for Use	RFMagik Lite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis	AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Prescription or OTC	Prescription	Prescription
Mode of Operation	Monopolar	Monopolar
Waveform	Oscillating rectangular wave	Oscillating rectangular wave
Output frequency	1MHz	1MHz
Output operating time	Min 50ms / Max 2,000ms	Min 50ms / Max 2,000ms
Output power levels	0~20 levels (0, 2 to 32W)	25 levels (2 to 46 W)
Max. output power	0, 2 ~ 32W at 200 ohm	2 ~ 46 W at 200 ohm
Electrical Safety Standards Complies	with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2	with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2
Connected Handpiece	Two Type of Handpiece1) RO Handpiece2) AGNES RF Handpiece	One Agnes RF handpiece
Connect Patient contact Electrode Tip
Sterilization	EO Gas	EO Gas
Shelf Life	3 Years	3 Years
FDA Cleared Tip	K171707(GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GAF1A)	K171707(GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GAF1A)
New Tips	RO-25S, RO-25D	N/A
Neutral electrode pad	510(k) cleared by FDA (K073360)	510(k) cleared by FDA (K102372)
Foot Switch	Single pedal, IPX8	Single pedal, IPX6

The different characteristics do not raise different questions of safety and effectiveness.

7. Non-Clinical Testing

1) Electrical Testing and EMC Testing
The electrical and EMC tests were performed with the compatible radio frequency electrosurgical devices in accordance with the FDA recognized standards,

AAMI ES60601-1:2005/AMD2:2021, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC60601-2-2:2017/AMD1:2023, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
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
TR IEC 60601-4-2: 2024 Medical electrical equipment. Guidance and interpretation. Electromagnetic

Page 10

immunity: performance of medical electrical equipment and medical electrical system

2) Biocompatibility
The biocompatibility tests were performed in accordance with the FDA recognized standards,

ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Test for irritation

3) Sterility
The EO gas sterilization was verified and validated in accordance with the FDA recognized standards

ISO 11135: 2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11138-1:2017, Sterilization of health care products - Biological Indicators – Part 1: General requirements
ISO 11138-2: 2017, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 10993-7: 2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

4) Shelf life

ISO 11607-1: 2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1929-15, Standard test method for detecting seal leaks in porous medical packaging by dye Penetration
ASTM F88M-21, Standard test method for seal strength of flexible barrier materials

5) Performance Testing
AGNES MEDICAL conducted bench testing to assure that the operates safely and within the predefined design specifications.

6) Ex Vivo Study
Ex Vivo testing conducted on three types of tissue – Liver, skin and Muscle under GLP Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" March 9, 2020

8. Conclusion

The RFMagik Lite and the predicate device have same indication for use, Technology, mechanism of actions, operational principles and performance for the proposed indications for use.

The non-clinical data for the subject 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 testing shows that the device is safe.

The comparison between the subject device and the predicate devices shows that the indication for use and technological characteristic are substantially equivalent although there are some differences, the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject device is substantially equivalent to the predicate devices.

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.