(266 days)
No
The summary describes a combination laser and electrosurgical device with manual controls and standard safety testing, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for medical procedures like ablative skin resurfacing, incision, excision, ablation, vaporization, coagulation, and hemostasis of body soft tissues, which are all therapeutic interventions aimed at treating a medical condition or altering the body's structure or function for medical purposes.
No
The device is described as a CO2 laser and HF electrosurgical system used for incision, excision, ablation, vaporization, coagulation, and hemostasis of body soft tissues. These are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly details hardware components such as a system main body, handpieces, footswitch, LCD touch screen, CO2 RF tube, and disposable micro-needle electrodes, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FRAXIS DUO is a surgical device that uses CO2 laser and HF electrosurgical energy to directly interact with and modify body tissues. It is used for procedures like incision, excision, ablation, vaporization, coagulation, and skin resurfacing.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is to apply energy to the body itself.
Therefore, the FRAXIS DUO falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI, OUH
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissues including intraoral tissues.
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)
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 DUO is safe for use and effective.
HF electrosurgical 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 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.
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.
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.
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
§ 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.
0
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
1
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
2
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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3
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, laser |
| Micro-needle Fractional RF | |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery |
| and 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. |
4
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 |
| 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.
5
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 /
Intensif Applicator (Ilooda
Secret) (K130501) | YOULASER CO2
(K123573) | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Ilooda | EndyMed Medical Ltd | Quanta System SpA | |
| 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. | | - CO2 LASER PART
YOULASER CO2 laser
when used in traditional, non
fractionated 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),
gynaecology,
neurosurgery, dental and
oral surgery and
genitourinary surgery.
YOULASER CO2laser
when used in
fractionated mode
(dot scanner) is indicated
only for ablative
skin resurfacing." | |
| | | FRAXIS DUO | EndyMed Pro /
Intensif Applicator (Ilooda
Secret) (K130501) | YOULASER CO2
(K123573) |
| | | -HF electrosurgical
Part :
The FRAXIS DUO is
intended for use in
dermatologic and
general surgical
procedures for electro-
coagulation and
hemostasis | The Intensif Applicator
is intended for use in
Dermatologic and
General Surgical
procedures for
electrocoagulation and
hemostasis. | |
| | Electrosurgical RF
applicator | Intensif Applicator
(Ilooda Secret)
(K130501) | Intensif Applicator
(Ilooda Secret) (K130501) | |
| | Output energy
type | CO2 / High frequency | High Frequency | CO2 |
| Delivery system | | Laser Part
Articulated Arm with
Scanner, Normal(Smart
surgi) Handpiece | - | Articulated arm +
Normal or Scanner
handpiece |
| | | High frequency Part
Bipolar Handpiece | Bipolar Handpiece | |
| Operation mode | | Laser Part
Fractional mode
Scanner handpiece
Normal mode
(CW, Pulse, Single
Pulse,Ultra)
Normal handpiece | | Fractional mode
Surgical mode
(CW, Pulse) |
| | | -HF electrosurgical
Part :
Manual mode | Intensif mode | |
| | User interface | Color Touch Panel | Color Touch Screen | Color Touch Screen |
| | Electrical
Requirements | 100-240VAC, 50/60Hz,
5-3A | 100-230 VAC, 50-60Hz
1-3A, | 115 V ac; 50/60 Hz;
1000 VA or
230 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) x
1150 (H) | Main unit :
480 (W) x 550(D) x
1200 (H)
Arm : Not known |
| | Weight
(Without arm) | 45kg | 33 kg | 55 Kg |
| | wavelength | 10,600nm | | |
| Spec.
_Laser | Medium of
transmission | 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 |
| | Scanning
pattern | | - | Area, Shape, Spot
density |
| | FRAXIS DUO | EndyMed Pro /
Intensif Applicator (Ilooda
Secret) (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) | 1x120x20 mm | - | 18x18mm |15min
| | Spot size | Fractional : 100 ~ 120 $\mu m$
Non-fractional : Max
1.3mm | - | Fractional :200 $\mu m$
Non-fractional :
200 $\mu$ m, 400 $\mu$ m, 1000 $\mu$ m |
| | Pulse repetition
(Fractional) | 1,000Hz | | Up to 1kHz |
| | Number of
microbeams per
surface
area
(Fractional) | Max 289 spot/cm2 | | 100, 200 & 500 spot/cm2 |
| | Energy per
Microbeam
(Fractional) | 150mJ | | Fluence per microbeam
9.9 ÷84.8 J/cm2
(from Quanta USA
website) |
| | Total power
per surface
area
(Fractional) | Max.30W | | Max 30W |
| | Treatment
distance | 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 | High
frequency | 2MHz ± 10% | 1MHz ± 10% | |
| | Max power | Max 25W at 500Ω | Max 25W at 500Ω | |
| | Total power
delivered
per
treatment | Max.25W | Max.25W | |
| | Power of
per electrode
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
(recommended) | 10~15min
(recommended) | |
| | Needle
insert
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 /
Intensif Applicator (Ilooda
Secret) (K130501) | YOULASER CO2
(K123573) |
| | Repetition | 0.2 / 0.5 / 1 / 2 sec /
Single | 0.2 / 0.5 / 1 / 2 sec /
Single | |
| | Connected
handpiece | Bipolar handpiece | Intensif handpiece
(Bipolar type) | |
| | Connected
electrodes | MTR-AC-25
MTR-AC-64 | Intensif 25 pin electrode | |
6
7
8
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
9
DUO is safe for use and effective.
HF electrosurgical 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 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.