FRAXIS DUO

K160312 · Ilooda Co,., Ltd. · GEX · Oct 28, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160312
• Device Name: FRAXIS DUO
• Applicant: Ilooda Co,., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Combination system featuring CO2 laser and HF electrosurgical modules; not used simultaneously. CO2 laser utilizes RF tube (10,600nm) with fractional or non-fractional handpieces for soft tissue ablation/coagulation. HF module uses bipolar handpiece with disposable micro-needle electrodes for electro-coagulation/hemostasis. Operated by physicians in clinical settings via LCD touch screen and footswitch. Laser energy delivered via articulated arm; HF energy delivered via needle array. Output parameters (power, pulse duration, depth) controlled by physician to optimize clinical effect. Benefits include precise tissue interaction for aesthetic and surgical applications.

Clinical Evidence

Bench testing only; no human clinical data. Performance supported by IEC 60601-1 (safety), IEC 60601-1-2 (EMC), EN 60825-1 (laser safety), and EN 60601-2-22. In vivo animal studies (micropig) evaluated histological ablation depth and thermal damage zones at various power/depth settings. Comparison with predicate device showed similar conical diamond-shaped tissue coagulation patterns in the dermis.

Technological Characteristics

Dual-modality system: CO2 laser (10,600nm, max 30W, air-cooled) and HF electrosurgical (2MHz, max 25W). Laser delivery via articulated arm; HF delivery via bipolar handpiece with disposable micro-needle electrodes (MTR-AC-25/64). User interface: LCD touch screen. Electrical: 100-240VAC. Biocompatibility per ISO 10993-1. Safety standards: IEC 60601-1, IEC 60601-1-2, EN 60825-1, EN 60601-2-22.

Indications for Use

Indicated for patients requiring ablative skin resurfacing (fractional mode), or incision, excision, ablation, vaporization, and coagulation of soft tissues (non-fractional mode) in dermatology, plastic surgery, ENT, gynecology, neurosurgery, dental, and oral surgery. Also indicated for electro-coagulation and hemostasis in dermatologic and general surgical procedures.

Regulatory Classification

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.

Predicate Devices

• YOULASER CO2 (K123573)
• Intensif Applicator (Ilooda Secret) (K130501)

Submission Summary (Full Text)

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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 [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

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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,<br>Suwon-Si Gyeonggido, KOREA, 16200 |
| Submitter's Telephone: | [phone] |
| Contact person: | Yun-Jung HA ([e-mail]) / RD Manager |
| Official Correspondent: | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |
| DEVICE | |
| Trade/proprietary name: | FRAXIS DUO |
| Common or Usual Name: | Instrument, surgical, powered, laser<br>Micro-needle Fractional RF |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology.<br>Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4810 (Product Code: GEX)<br>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 plastic<br>surgery 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.

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

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE IV. DEVICE

| | FRAXIS DUO | EndyMed Pro /<br>Intensif Applicator (Ilooda<br>Secret) (K130501) | YOULASER CO2<br>(k123573) | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Ilooda | EndyMed Medical Ltd | Quanta System SpA | |
| Intended use | - CO2 LASER Part:<br>Fractional mode is<br>indicated only for<br>ablative skin<br>resurfacing.<br>Non-fractional mode is<br>indicated for incision,<br>excision, ablation,<br>vaporization and<br>coagulation of body<br>soft tissues including<br>intraoral tissues, in<br>medical specialties<br>including aesthetic<br>(dermatology and<br>plastic surgery),<br>otorhinolaryngology<br>(ENT), gynecology,<br>neurosurgery, dental<br>and oral surgery and<br>genitourinary surgery. | | - CO2 LASER PART<br>YOULASER CO2 laser<br>when used in traditional, non<br>fractionated mode is<br>indicated for: incision,<br>excision, ablation,<br>vaporization and<br>coagulation of body soft<br>tissues including<br>intraoral tissues, in<br>medical specialties<br>including aesthetic<br>(dermatology and plastic<br>surgery),<br>otorhinolaryngology (ENT),<br>gynaecology,<br>neurosurgery, dental and<br>oral surgery and<br>genitourinary surgery.<br>YOULASER CO2laser<br>when used in<br>fractionated mode<br>(dot scanner) is indicated<br>only for ablative<br>skin resurfacing." | |
| | | FRAXIS DUO | EndyMed Pro /<br>Intensif Applicator (Ilooda<br>Secret) (K130501) | YOULASER CO2<br>(k123573) |
| | | -HF electrosurgical<br>Part :<br>The FRAXIS DUO is<br>intended for use in<br>dermatologic and<br>general surgical<br>procedures for electro-<br>coagulation and<br>hemostasis | The Intensif Applicator<br>is intended for use in<br>Dermatologic and<br>General Surgical<br>procedures for<br>electrocoagulation and<br>hemostasis. | |
| | Electrosurgical RF<br>applicator | Intensif Applicator<br>(Ilooda Secret)<br>(K130501) | Intensif Applicator<br>(Ilooda Secret) (K130501) | |
| | Output energy<br>type | CO2 / High frequency | High Frequency | CO2 |
| Delivery system | | Laser Part<br>Articulated Arm with<br>Scanner, Normal(Smart<br>surgi) Handpiece | - | Articulated arm +<br>Normal or Scanner<br>handpiece |
| | | High frequency Part<br>Bipolar Handpiece | Bipolar Handpiece | |
| Operation mode | | Laser Part<br>Fractional mode<br>Scanner handpiece<br>Normal mode<br>(CW, Pulse, Single<br>Pulse,Ultra)<br>Normal handpiece | | Fractional mode<br>Surgical mode<br>(CW, Pulse) |
| | | -HF electrosurgical<br>Part :<br>Manual mode | Intensif mode | |
| | User interface | Color Touch Panel | Color Touch Screen | Color Touch Screen |
| | Electrical<br>Requirements | 100-240VAC, 50/60Hz,<br>5-3A | 100-230 VAC, 50-60Hz<br>1-3A, | 115 V ac; 50/60 Hz;<br>1000 VA or<br>230 V ac; 50/60 Hz;<br>1000 V A |
| Dimensions<br>(mm) | | Main unit :<br>410(W)x601(D)x1071(H)<br>Arm : Max 1,400(H)mm | Main Unit:<br>190 (W) x 300 (D) x<br>1150 (H) | Main unit :<br>480 (W) x 550(D) x<br>1200 (H)<br>Arm : Not known |
| | Weight<br>(Without arm) | 45kg | 33 kg | 55 Kg |
| | wavelength | 10,600nm | | |
| Spec.<br>_Laser | Medium of<br>transmission | CO2 Laser | - | CO2 Laser |
| | Aiming beam | Diode laser(Red),<br>Max 4mW, 655nm | - | Red Laser Diode,<br>3mW |
| | power | Max 30W | - | Max 30W |
| | Cooling | Air cooling | - | Air cooling |
| | Scanning<br>pattern | | - | Area, Shape, Spot<br>density |
| | FRAXIS DUO | EndyMed Pro /<br>Intensif Applicator (Ilooda<br>Secret) (K130501) | YOULASER CO2<br>(k123573) | |
| | (Fractional)<br>Image: [Fractional] | | | |
| | Pulse energy<br>(Fractional) | Max 150mJ | - | Up to 3J |
| | Pulse duration<br>(Fractional) | $20 \mu s \sim 5,000 \mu s$ | - | $50 \mu s - 20.000 \mu s$ |
| | Distance<br>(Fractional) | 1x1~20x20 mm | - | 18x18mm |
| | Spot size | Fractional : 100 ~ 120 $\mu m$<br>Non-fractional : Max<br>1.3mm | - | Fractional :200 $\mu m$<br>Non-fractional :<br>200 $\mu$ m, 400 $\mu$ m, 1000 $\mu$ m |
| | Pulse repetition<br>(Fractional) | 1,000Hz | | Up to 1kHz |
| | Number of<br>microbeams per<br>surface<br>area<br>(Fractional) | Max 289 spot/cm2 | | 100, 200 & 500 spot/cm2 |
| | Energy per<br>Microbeam<br>(Fractional) | 150mJ | | Fluence per microbeam<br>9.9 ÷84.8 J/cm2<br>(from Quanta USA<br>website) |
| | Total power<br>per surface<br>area<br>(Fractional) | Max.30W | | Max 30W |
| | Treatment<br>distance | 0.1mm - 2.0mm | | Not known |
| | Treatment time | 10-15min | | Not known |
| | Pulse rate<br>(Non-<br>fractional) | 1Hz - 1,000Hz | - | 2,000Hz |
| | Pulse width<br>(Non-<br>fractional) | Ultra : $20 \mu s \sim 5000 \mu s$ | | Surgical : up to 100 ms |
| Spec.<br>HF | High<br>frequency | 2MHz ± 10% | 1MHz ± 10% | |
| | Max power | Max 25W at 500Ω | Max 25W at 500Ω | |
| | Total power<br>delivered<br>per<br>treatment | Max.25W | Max.25W | |
| | Power of<br>per electrode<br>pin | 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<br>(recommended) | 10~15min<br>(recommended) | |
| | Needle<br>insert<br>depth | 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 /<br>Intensif Applicator (Ilooda<br>Secret) (K130501) | YOULASER CO2<br>(k123573) |
| | Repetition | 0.2 / 0.5 / 1 / 2 sec /<br>Single | 0.2 / 0.5 / 1 / 2 sec /<br>Single | |
| | Connected<br>handpiece | Bipolar handpiece | Intensif handpiece<br>(Bipolar type) | |
| | Connected<br>electrodes | MTR-AC-25<br>MTR-AC-64 | Intensif 25 pin electrode…