CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Device Description

FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system. The Laser and High Frequency(=Radio frequency) can not be used simultaneously. FRAXIS DUO's CO2 laser includes the system main body, different handpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel. FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The laser are supplied with different handpieces depending upon the device configuration. FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered using disposable micro-needle electrodes.

AI/ML Overview

The provided text describes the FRAXIS DUO device and its predicates, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the document details a substantial equivalence determination by the FDA for the FRAXIS DUO to legally marketed predicate devices. This determination is based on a comparison of technological characteristics, indications for use, and performance data. The performance data provided is primarily non-clinical and animal testing to demonstrate safety and similar tissue effects to the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with quantitative metrics and their corresponding reported device performance values for the FRAXIS DUO. Instead, it relies on demonstrating comparable performance and safety to predicate devices through a series of tests.

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

Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or individuals for a clinical test set. The "test set" here refers to animal models for safety and histological evaluation.
- Laser Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
- HF Electrosurgical Part Animal Testing: "In vivo animal testing using micropig models was also conducted..." (Number of micropigs not specified).
Data Provenance: The animal studies were "In vivo animal testing using micropig models." The country of origin of the data is not specified, but the manufacturer is ILOODA CO LTD. from South Korea. The studies are prospective in nature, as they involve conducting tests on live animals to gather data.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: The histological evaluations were performed to assess "depth and zone of ablation and thermal damage." It is implied that qualified personnel (e.g., veterinary pathologists or dermatopathologists) conducted these evaluations, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned.

4. Adjudication Method for the Test Set:

Adjudication Method: Not described. The text mentions "Histologic evaluation was done by H&E for immediately after procedure" and that "Histologically, both FRAXIS DUO and predicate device created tissue coagulation in the dermis and show similar coagulated pattern." This implies a single assessment for each sample, rather than a multi-reader adjudication process.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical and animal testing for safety and technological equivalence, not on human reader performance or improvements with AI assistance. The device is a physical instrument, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The FRAXIS DUO is a laser and electrosurgical instrument for therapeutic use, not an algorithm, so a standalone algorithm performance study is irrelevant to this device.

7. Type of Ground Truth Used:

For the animal studies, the "ground truth" was established through histological evaluation (H&E staining) of tissue samples from the micropigs, assessing the "depth and zone of ablation and thermal damage." This is a form of pathology-based ground truth for observable tissue effects.

8. Sample Size for the Training Set:

Not applicable. This device is a therapeutic medical instrument, not a machine learning or AI model that requires a training set. The performance data is based on engineering tests and animal studies.

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

Not applicable, as there is no training set for this device.

Summary regarding "Acceptance Criteria and Study":

The document details the FDA's 510(k) clearance process based on substantial equivalence to predicate devices. This means the FRAXIS DUO demonstrated that it is as safe and effective as existing legally marketed devices.

The "study" that supports this is a combination of:

Biocompatibility testing (ISO10993-1;2009 for patient contact materials).
Non-clinical testing for electrical safety (IEC 60601-1, IEC 60601-1-2) and laser safety (EN 60825-1, EN 60601-2-22).
In vivo animal testing using micropig models to histologically evaluate the depth and zone of ablation and thermal damage immediately, 7 days, and 14 days post-treatment for both the CO2 laser part and the HF electrosurgical part. An additional preclinical test compared 2MHz and 1MHz high-frequency characteristics on tissue.

The "acceptance criteria" were implicitly met by demonstrating that the device fulfilled the requirements of the specified standards and that the animal study results showed the fractional and non-fractional modes were "safe for use and effective" and produced "similar coagulated pattern[s]" to the predicate device in histological evaluations. There were no explicit numerical cut-offs or performance targets presented as "acceptance criteria" in this summary.

Summary

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle symbol.

Public Health Service

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

October 28, 2016

Ilooda Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K160312

Trade/Device Name: Fraxis Duo Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, GEI, OUH Dated: January 27, 2016 Received: February 5, 2016

Dear Dave Kim:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

510(k) Number (if known) K160312

Device Name FRAXIS DUO Instrument, surgical, powered, laser Micro-needle Fractional RF

Indications for Use (Describe)

- CO2 LASER Part:

Fractional mode is indicated only for ablative skin resurfacing.

Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation 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)

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Traditional 510(k) Summary

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

Date 510k summary prepared: October 20, 2016

I. SUBMITTER

Submitter's Name :	ILOODA CO LTD.
Submitter's HQ Address:	120, Jangan-ro 458 Beon-gil, Jangan-Gu,Suwon-Si Gyeonggido, KOREA, 16200
Submitter's Telephone:	+82 (031) 210 1622
Contact person:	Yun-Jung HA (yjha@ilooda.com) / RD Manager
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988
DEVICE
Trade/proprietary name:	FRAXIS DUO
Common or Usual Name:	Instrument, surgical, powered, laserMicro-needle Fractional RF
Regulation Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.Electrosurgical, cutting & coagulation device & accessories
Regulation Number:	21 CFR 878.4810 (Product Code: GEX)21 CFR 878.4400 (Product Code: GEI, OUH)
Regulatory Class:	Class II
Prescription Use.

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PREDICATE DEVICE

Primary Device Manufacturer:	Quanta System SpA
Device Name:	YOULASER C02
510(k) Number:	K123573
Regulation Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Regulation Number:	21 CFR 878.4810 (Product Code: GEX)
Regulatory Class:	Class II

This predicate has not been subject to a design-related recall.

Reference Device Manufacturer:	EndyMed Medical Ltd
Device Name:	Intensif Applicator (Ilooda Secret)
510(k) Number:	K130501
Regulation Name:	Electrosurgical, cutting & coagulation device & accessories
Regulation Number:	21 CFR 878.4400 (Product Code: OUH, GEI)
Regulatory Class:	Class II
This predicate has not been subject to a design-related recall.

DEVICE DESCRIPTION II.

FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system.

The Laser and High Frequency(=Radio frequency) can not be used simultaneously.

FRAXIS DUO's CO2 laser includes the system main body, differenthandpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel.

FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece.

The laser are supplied with different handpieces depending upon the device configuration.

FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel.

The HF energy is delivered using disposable micro-needle electrodes.

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INDICATIONS FOR USE: III.

CO2 LASER Part: ।

Fractional mode is indicated only for ablative skin resurfacing.

HF electrosurgical part -

The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE IV. DEVICE

	FRAXIS DUO	EndyMed Pro /Intensif Applicator (IloodaSecret) (K130501)	YOULASER CO2(K123573)
Manufacturer	Ilooda	EndyMed Medical Ltd	Quanta System SpA
Intended use	- CO2 LASER Part:Fractional mode isindicated only forablative skinresurfacing.Non-fractional mode isindicated for incision,excision, ablation,vaporization andcoagulation of bodysoft tissues includingintraoral tissues, inmedical specialtiesincluding aesthetic(dermatology andplastic surgery),otorhinolaryngology(ENT), gynecology,neurosurgery, dentaland oral surgery andgenitourinary surgery.		- CO2 LASER PARTYOULASER CO2 laserwhen used in traditional, nonfractionated mode isindicated for: incision,excision, ablation,vaporization andcoagulation of body softtissues includingintraoral tissues, inmedical specialtiesincluding aesthetic(dermatology and plasticsurgery),otorhinolaryngology (ENT),gynaecology,neurosurgery, dental andoral surgery andgenitourinary surgery.YOULASER CO2laserwhen used infractionated mode(dot scanner) is indicatedonly for ablativeskin resurfacing."
		FRAXIS DUO	EndyMed Pro /Intensif Applicator (IloodaSecret) (K130501)	YOULASER CO2(K123573)
		-HF electrosurgicalPart :The FRAXIS DUO isintended for use indermatologic andgeneral surgicalprocedures for electro-coagulation andhemostasis	The Intensif Applicatoris intended for use inDermatologic andGeneral Surgicalprocedures forelectrocoagulation andhemostasis.
	Electrosurgical RFapplicator	Intensif Applicator(Ilooda Secret)(K130501)	Intensif Applicator(Ilooda Secret) (K130501)
	Output energytype	CO2 / High frequency	High Frequency	CO2
Delivery system		Laser PartArticulated Arm withScanner, Normal(Smartsurgi) Handpiece	-	Articulated arm +Normal or Scannerhandpiece
		High frequency PartBipolar Handpiece	Bipolar Handpiece
Operation mode		Laser PartFractional modeScanner handpieceNormal mode(CW, Pulse, SinglePulse,Ultra)Normal handpiece		Fractional modeSurgical mode(CW, Pulse)
		-HF electrosurgicalPart :Manual mode	Intensif mode
	User interface	Color Touch Panel	Color Touch Screen	Color Touch Screen
	ElectricalRequirements	100-240VAC, 50/60Hz,5-3A	100-230 VAC, 50-60Hz1-3A,	115 V ac; 50/60 Hz;1000 VA or230 V ac; 50/60 Hz;1000 V A
Dimensions(mm)		Main unit :410(W)x601(D)x1071(H)Arm : Max 1,400(H)mm	Main Unit:190 (W) x 300 (D) x1150 (H)	Main unit :480 (W) x 550(D) x1200 (H)Arm : Not known
	Weight(Without arm)	45kg	33 kg	55 Kg
	wavelength	10,600nm
Spec._Laser	Medium oftransmission	CO2 Laser	-	CO2 Laser
	Aiming beam	Diode laser(Red),Max 4mW, 655nm	-	Red Laser Diode,3mW
	power	Max 30W	-	Max 30W
	Cooling	Air cooling	-	Air cooling
	Scanningpattern		-	Area, Shape, Spotdensity
	FRAXIS DUO	EndyMed Pro /Intensif Applicator (IloodaSecret) (K130501)	YOULASER CO2(K123573)
	(Fractional)Image: [Fractional]
	Pulse energy(Fractional)	Max 150mJ	-	Up to 3J
	Pulse duration(Fractional)	$20 \mu s \sim 5,000 \mu s$	-	$50 \mu s - 20.000 \mu s$
	Distance(Fractional)	1x1~20x20 mm	-	18x18mm
	Spot size	Fractional : 100 ~ 120 $\mu m$Non-fractional : Max1.3mm	-	Fractional :200 $\mu m$Non-fractional :200 $\mu$ m, 400 $\mu$ m, 1000 $\mu$ m
	Pulse repetition(Fractional)	1,000Hz		Up to 1kHz
	Number ofmicrobeams persurfacearea(Fractional)	Max 289 spot/cm2		100, 200 & 500 spot/cm2
	Energy perMicrobeam(Fractional)	150mJ		Fluence per microbeam9.9 ÷84.8 J/cm2(from Quanta USAwebsite)
	Total powerper surfacearea(Fractional)	Max.30W		Max 30W
	Treatmentdistance	0.1mm - 2.0mm		Not known
	Treatment time	10-15min		Not known
	Pulse rate(Non-fractional)	1Hz - 1,000Hz	-	2,000Hz
	Pulse width(Non-fractional)	Ultra : $20 \mu s \sim 5000 \mu s$		Surgical : up to 100 ms
Spec.HF	Highfrequency	2MHz ± 10%	1MHz ± 10%
	Max power	Max 25W at 500Ω	Max 25W at 500Ω
	Total powerdeliveredpertreatment	Max.25W	Max.25W
	Power ofper electrodepin	Max.25W	Max.25W
	Power density	41W/cm²	41W/cm²
	Current density	0.3A/cm²	0.3A/cm²
	RF duration	50 ms ~ 950 ms	50 ms ~ 950 ms
	Treatment time	10~15min(recommended)	10~15min(recommended)
	Needleinsertdepth	0.5 ~ 3.5mm (0.1 step)	0.5 ~ 3.5mm (0.1 step)
	Intensity	0 ~ 10 LEVEL	0 ~ 10 LEVEL
		FRAXIS DUO	EndyMed Pro /Intensif Applicator (IloodaSecret) (K130501)	YOULASER CO2(K123573)
	Repetition	0.2 / 0.5 / 1 / 2 sec /Single	0.2 / 0.5 / 1 / 2 sec /Single
	Connectedhandpiece	Bipolar handpiece	Intensif handpiece(Bipolar type)
	Connectedelectrodes	MTR-AC-25MTR-AC-64	Intensif 25 pin electrode

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PERFORMANCE DATA V.

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility testing:

FRAXIS DUO is equipped with the electrosurgical RF applicator, Intensif Applicator (Ilooda Secret), K130501. The patient contact components and materials are tested and validated according to ISO10993-1;2009.

Non Clinical testing:

IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.

IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.

EN 60825-1: Safety of laser products-Part 1: Equipment classification and requirements EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment.

The requirements of specified standards were fulfilled.

Animal testing :

Laser part

In vivo animal testing using micropig models was also conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 7 days post treatment; and 14 days post treatment.

The animal study results show that fractional mode and non-fractional mode of FRAXIS

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DUO is safe for use and effective.

HF electrosurgical part

The treatment was performed at the intensity(power) low, mid, high and depth of microneedling 1.0mm, 2.0mm, 3.0mm.

Additional preclinical performance test was performed to investigate animal study comparing the 2MHz and 1MHz high-frequency characteristics effect on tissue.

FRAXIS DUO and predicate device were performed in the same condition(Depth : 2.0mm, Power : 30W).

Histologic evaluation was done by H&E for immediately after procedure.

Histologically, both FRAXIS DUO and predicate device created conical diamond shaped tissue coagulation in the dermis and show similar coagulated pertten.

Histologically, both FRAXIS DUO and predicate device created tissue coagulation in the dermis and show similar coagulated pattern.

CONCLUSIONS VI.

There are no significant differences between the FRAXIS DUO and the predicate device. The proposed device does not raise any questions regarding safety and effectiveness.

FRAXIS DUO has the same indications for use as the predicate devices.

It shares the same technological characteristics as the predicate devices.

Some minor differences do not raise any new questions regarding safety or effectiveness of FRAXIS DUO.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Ilooda Co, Ltd. concludes that FRAXIS DUO is safe and effective and substantially equivalent in comparison with Intensif Applicator (Ilooda Secret) (K130501) and YOULASER CO2 (K123573), the predicate devices

as described herein.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.