AGNES

• K Number: K160469
• Device Name: AGNES
• Manufacturer: GOWOONSESANG COSMETICS CO., LTD
• Date Cleared: 2017-01-05 ( 321 days)
• Product Code: GEI KCW THE
• Regulation Number: 878.4400

Intended Use

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Device Description

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.

Predicate Devices

K881276, K153727

Reference Devices

K12336, K102372

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related concepts, and the device description is of a standard RF electrosurgical device.

Therapeutic

Yes
The device is described as an electrocoagulation and hemostasis device for dermatological and general surgical procedures, which are therapeutic interventions. The animal study results also discuss "destruction of sebaceous glands" and "quick treatment and preventing reoccurrence" for acne, implying a therapeutic effect.

Diagnostic

No

The device description clearly states its purpose as an "RF electrosurgical device" for "electrocoagulation and hemostasis" in dermatological and general surgical procedures, which are therapeutic functions, not diagnostic ones. Its "Intended Use" also focuses on treatment (electrocoagulation and hemostasis), not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an LCD screen, radiofrequency generator, SMPS, hand-piece, electrodes, neutral electrode pad, and footswitch.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "electrocoagulation and hemostasis in dermatological and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
• Device Description: The device is described as an "RF electrosurgical device" with components like a generator, hand-piece, electrodes, and a neutral electrode pad. These are typical components of surgical devices used for tissue manipulation.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply radiofrequency energy to tissue for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Product codes (comma separated list FDA assigned to the subject device)

GEI, KCW

Device Description

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing - Nonclinical:

• Electrosurgical Unit: RF output power testing was performed in accordance with IEC 60601-2-2:2009.
• Active Component - Disposable RF electrode (Needle type): Mechanical testing (mechanical failure and short circuiting), Electrical performance (insulation integrity), Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10), and Sterility and packing (ISO 11135, ISO 11138-2, ISO 10993-7, ISO 11607-1, ASTM F1980-07) tests were performed.
• Disposable Neutral Electrode Pad: Thermal performance, contact impedance, and adhesion testing was performed in accordance with IEC 60601-2-2:2009.
• Miscellaneous component - Foot Switch: Design specification and performance test was performed in accordance with IEC 60601-2-2:2009.

Performance Testing - Animal:

• Study type: Animal study conducted on mini pigs and rabbit's ear models to measure penetration depth and assess improvement of acne.
• Macroscopic assessment by dermatologists on damage and safety on the skin surface and inside the corium. Photo taking with a camera (EOS D3000, Cannon, Tokyo, Japan). Checking skin conditions using a folliscope magnifying glass (LeedM. Seoul, Korea). Assessment of acne lesion reduction using a 3D measuring instrument PRIMOS Pico (GFM, Germany).
• Histological assessment: Skin extracted from rabbit's ear, fixed with 4% paraformaldehyde, dehydrated, embedded in paraffin, sectioned (5 microm or smaller), deparaffinized, dyed with hematoxylin & eosin to check epidermis condition and sebaceous glands dispersion.
• Key results:
  1. Accurate penetration depth, with distinct coagulation of skin in mini pigs.
  2. Rabbit's ear models successfully developed with acne lesions (closed comedos, papules, pustules) after intradermal injection of P. acnes and oleic acid.
  3. AGNES treatment on graded groups resulted in destruction of sebaceous glands and significant reduction of inflammatory cells, papule, and pustule in the lesion area.
  4. Destruction of sebaceous glands killed acne bacteria, induced fast inflammation relief, and helped quick treatment, considered a valid method to prevent reoccurrence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K881276, K153727

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K12336 (mentioned in differences, for needle length comparison)
K102372 (for disposable neutral electrode pad clearance)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 5, 2017

GOWOONSESANG Cosmetics Co., Ltd % DongHa Lee Regulatory Affairs Consultant KMC. Inc. Room No. 409, ACE Technotower 1-Cha, 38-9, Digital-ro 31-gil, Guro-gu Seoul, Korea 152-766 KR

Re: K160469

Trade/Device Name: AGNES Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, KCW Dated: November 4, 2016 Received: November 8, 2016

Dear DongHa 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 (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 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Jennifer R. Stevenson -A 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

2

Indications for Use

510(k) Number (if known) K160469

Device Name AGNES

Indications for Use (Describe)

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Type of Use (Select one or both, as applicable)

X 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 [e-mail]

"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."

3

510(k) Summary (K160469)

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

Date: January 3, 2017

1. Applicant / Submitter

GOWOONSESANG COSMETICS CO., LTD Address: (Seohyeon-dong, 4, 5F Cocoplaza), 20, Seohyeon-ro 210beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea (Postal code: 13591) Tel : [phone] Fax : [phone]

2. Submission Contact Person

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, Korea Tel: [phone] Fax: [phone] Email: [e-mail]

3. Device Information

• Trade Name: AGNES
• Common Name: RF Electrosurgical Device
• Classification Name: Electrosurgical cutting and coagulation device and accessories
• Classification Product Code and Regulation: GEI, 21CFR 878.4400
• Subsequent Product Code and Regulation: KCW, 21CFR878.5350
• Device Class: 2

4. Predicate Device

	Predicate Device(1)	Predicate Device(2)
Manufacturer	Jeisys Medical Incorporated	IME Co., Ltd.
Device Name	INTRAcel Premium Fractional
RF Micro Needle (FRM) System	HR-5000
510(k) number	K153727	K881276

5. Description

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a hand-piece, Single use RF electrodes (needle type). Disposable

4

neutral electrode pad and a footswitch.

6. Indication for use

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

7. Substantial Equivalence

AGNES is substantially equivalent to the predicate device, HR-5000 (K881276) by IME Co., Ltd. The following comparison table is presented to demonstrate substantial equivalence.

Descriptive Information	Subject Device	Predicate Device (1)	Predicate Device (2)
Manufacturer	Gowoonsesang
Cosmetics Co., Ltd.	Jeisys Medical
Incorporated	IME Co., Ltd.
Device Name	AGNES	INTRAcel Premium
Fractional RF Micro
Needle (FRM) System	HR-5000
510(k) number	K160469	K153727	K881276
Classification Product Code /
Regulatory Number	GEI / 878.4400	GEI / 878.4400	KCW / 878.5350
Subsequent Product Code	KCW / 878.5350	-	-
Regulatory Class	2	2	1
Indications for Use	AGNES is indicated
for use in
dermatological and
general surgical
procedures for
electrocoagulation and
hemostasis.	INTRAcel Premium
Fractional RF Micro
Needle (FRM) System
device is indicated for
use in dermatological
and general surgical
procedures for
electrocoagulation and
hemostasis.	Epilation.
Dermatologic
indications,
specifically:
telangiectasia, port
wine stain, adenoma
sebaceum,
angiokeratoma,
angioma, nevus cell
nevi, syringoma, acne,
rosacea, senile ectasia,
rhinophyma, and
lymphangiomas.
Prescription or OTC	Prescription	Prescription	Prescription
Operation	The device uses RF
energy delivered
through micro needle
electrode to apply heat
to target tissue for
coagulating.	The device uses RF
energy delivered
through micro needle
electrode to apply heat
to target tissue for
coagulating.	The device uses RF
energy delivered
through micro needle
electrode to apply heat
to target tissue for
coagulating.
Electrosurgical
Unit (ESU)	Monopolar
or Bipolar	Monopolar	Bipolar
	Temperature
sensors	None	None
	Impedance
monitor	None	None	None
	Continuity
monitor	Checking the
connection between the
neutral electrode and
the electrosurgical unit.	None	Unknown
	Electrode
monitor	Provide a camera to
monitor the electrode
coating condition and
shape before using by
the user.	None	None
	Output
frequency	1MHz	1MHz	1MHz
	Waveform	Oscillating rectangular
wave	Unknown	Oscillating rectangular
wave
	Power
output	2 to 46 W at 200 ohm	12.5 to 50W at 200
ohm	5 to 50W at 200 ohm
	Voltage
output	25 to 104V	Unknown	10 to 90V
	Dimensions	290mm(W)x455mm(L)
x271.7mm(H)	350mm(W)x405mm(L)
x1080mm(H)	247mm(W)x270mm(L)
x127mm(H)
	Weight	5.8Kg	63Kg	5.2kg
	Power Input	100-250VAC, 50-60Hz	120VAC, 50/60 Hz	100-240VAC,
	FDA
Approval	None	None	None
	Monopolar
or Bipolar	Monopolar	Bipolar	Monopolar
	Electrode
type	Micro Needle type	Micro Needle type	Micro Needle type
Active
accessory
(RF Electrode)	Physical
Dimensions	Needle length :
0.8/1.25/1.5/ 2.0 mm
Thickness : 0.2mm	Needle length :
0.5/0.8/1.5/2.0mm
Thickness : 0.25mm	Needle length: 1.5mm
	Materials	Electrode: STS 304,
Insulating Coating: p-
xylylene dimer C	ABS + SUS304	Material: STS 304,
Insulating Coating:
Teflon PTFE
	Single Use
or Reusable	Single Use	Single Use	Single Use
	Sterilization	EO gas	EO gas	EO gas
Neutral
electrode pad	Approval	510(k) cleared by FDA
(Κ102372).	None	Unknown
	Conductive
Or
Capacitive	Conductive area:
132cm²	None	Unknown
	Single Use
or Reusable	Single Use	None	Unknown
	Physical
Specification	Mono-polar	None	Mono-polar
	Materials	Conductive material:
Metal foil
Backing material:
Foam backing	None	Metal plate
Miscellaneous
accessory
(Foot switch)	Functions	For emitting RF energy
into electrode.	For emitting RF energy
into electrode.	For emitting RF energy
into electrode.
	Performance
Specifications	Single pole, single
throw	Single pole, single
throw	Single pole, single
throw
	Physical
Specification	Single pedal, IP68	Single pedal, IPX8	Single pedal, Unknown
	Materials	Plastic, SPCC	Unknown	Plastic, SPCC

5

6

7.1 The same between the subject device and the predicates device.

• 1. Product Code
     : The proposed product code of the subject device is GEI for electrosurgical function. It is the same product code as the predicate device in K153727. The proposed product also has subsequent product code as KCW for epilation function. It is the same product code as the predicate device in K881276.

2) Regulatory number and classification

: The proposed regulatory number of the subject device is 878.4400 and the classification is 2. It is the same regulatory number and classification as the predicate device in K153727.

3) Indications for Use

: The subject device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. It is the same as the predicate device in K153727.

4) Prescription Use

: The subject device is a prescription use device. It is the same as the predicate devices in K153727 and K881276.

5) Operation

: The principle of operation of the subject device is using RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. It is the same as the predicate devices in K153727 and K881276.

6) Technical characteristic

: The subject device is monopolar function. It is the same as the predicate device in K881276. The subject device has 1MHz frequency output. It is the same as the predicate devices in K153727 and K881276.

7) Electrode

: The subject device uses disposable sterilized needle type electrode to delivery RF energy to the

7

target tissue. It is the same as the predicate devices. For monopolar function, the subject device uses a neutral electrode to be attached the patient back. It is the same as the predicate device in K881276.

8) Miscellaneous accessory

: The subject device uses a footswitch (Single pole, single throw) to emit RF energy into electrode. It is the same as the predicate devices.

7.2 Differences between Subject and Predicates Devices

1. ESU

: The subject device has different RF output power (2 to 46 W). The range of output power is within the predicate devices and the output was also evaluated by safety and performance tests according to IEC 60601-1, IEC 60601-2-2 and animal testing. The results show that these difference does not raise any problems in the safety and effectiveness.

2) Electrode

: The subject device has different electrode physical dimensions (Needle length: 0.8/1.25/1.5/ 2.0 mm, Thickness: 0.2mm). The target tissue is located in dermis (average depth from 0.5mm to 2.0mm). The predicate devices (needle length 0.5/0.8/1.5/2.0mm in K153727, 0.5 to 2.0 mm in K12336 and 1.5mm in K881276) also has target tissue located in dermis. The electrode is coated by different insulating coating material p-xylylene dimer C. Thermal effect was evaluated by animal testing. The results show that these difference does not raise any problems in the safety and effectiveness.

8. Electrical Safety and Electromagnetic compatibility

The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.

• -IEC 60601-1: 2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-2-2: 2009, 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, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

9. Performance Testing - Nonclinical

• 9.1 Electrosurgical Unit
• 1. RF output power testing

8

The tests were performed in accordance with the FDA recognized standard, IEC 60601-2-2:2009, Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Clause 201.11 and 201.12

9.2 Active Component - Disposable RF electrode (Needle type)

1. Mechanical testing (mechanical failure and short circuiting)

2. Electrical performance (insulation integrity)

The tests were performed with the RF surgical unit in accordance with the FDA recognized standard,

• -IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Clause 201.8, 201.13 and 201.15
• 3. Biocompatibility

The 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: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
• 4. Sterility and packing

The sterilization and packing is verified and validated in 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 11138-2: 2006, 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
• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ASTM F1980-07: 2011, Standard guide for accelerated aging of sterile barrier systems for medical devices.
• 9.3 Disposable Neutral Electrode Pad

9

The disposable neutral electrode pad is received prior 510(k) clearance by FDA (K102372).

1. Thermal performance, contact impedance, and adhesion testing

The tests were performed with the RF electrosurgical unit in accordance with the FDA recognized standard,

• IEC 60601-2-2:2009, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Sub-clause 201.15.101.
  9.4 Miscellaneous component - Foot Switch

1. Design specification and performance test.

The tests were performed with the RF electrosurgical unit in accordance with the FDA recognized standard,

• -IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency, Sub-clause 201.8.10.4. 201.11.6.5 and 201.12.2

10. Performance Testing - Animal

This animal study was conducted to measure the penetration depth and do a macroscopic check on the improvement of acne and histological pathology analyses on the animal model of acne through clinical assessment (photo assessment) and histological evaluation.

1) Microscopic assessment

• Macroscopic assessment by dermatologist on damage and safety on the skin surface and inside the corium

• Photo taking with a camera (EOS D3000, Cannon, Tokyo, Japan)

• Check the skin conditions using a folliscope magnifying glass (LeedM. Seoul, Korea)

• Assess reduction of acne lesion using 3 dimensional measuring instrument PRIMOS Pico (GFM, Germany)

2) Historical assessment

Extract skin on the rabbit's ear at the end of the test and fix with a 4% paraformaldehyde. Dehydrate with alcohol and xylene by stage and embed with paraffin. Make a fragment of 5 m or smaller using a microtome, and remove paraffin with alcohol and xylene again. Dye with hematoxylin & eosin and check the condition of the epidermis and dispersion of sebaceous glands.

10

This animal study results as the below.

1. We checked the depth of skin penetration and discovered that the penetration depth was relatively accurate. For mini pigs, we found distinct coagulation of skin on the area applied with RF.

2. In order to make the rabbit's ear model, we conducted intradermal injection of acne bacteria P. acnes and induced oleic acid for 4 weeks. As a result, we found acne lesions such as closed comedos and papules or pustules.

3. We selected groups by each grade and conducted the Agnes treatment, and discovered that the sebaceous glands were destroyed and inflammatory cells, papule and pustule on the lesion area were greatly reduced.

4. The destruction of sebaceous glands by Agnes killed acne bacteria and induced fast relief of inflammation, and helped quick treatment that it is considered as a valid method to prevent reoccurrence.

11. Conclusion

In comparing between the subject device and the predicate devices, there are indications for use, the operating principle and technological characteristics (monopolar function, output frequency). Although there are some differences as output power, electrode physical dimensions and electrode insulating coating material, the safety and performance test reports are supported to the safety and effectiveness of the subject device. The result of animal study is also supported to thermal effects on tissue and the intended use of the subject device.

In this regard, we conclude that the subject device is substantially equivalent to the predicate devices.