(29 days)
No
The document describes a CO2 laser device and its components, intended uses, and performance testing based on electrical and laser safety standards. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in the provided text.
Yes
The device is used for medical procedures such as incision, excision, ablation, vaporization, and coagulation of body soft tissues, which falls under therapeutic applications.
No
Explanation: The device description and intended use clearly state that it is a CO2 laser used for tissue modification (e.g., ablative skin resurfacing, incision, excision, vaporization) rather than for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a main console unit, delivery handpieces, and a footswitch, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states that this is a CO2 laser used for surgical procedures on body soft tissues. It involves direct interaction with the patient's body for incision, excision, ablation, vaporization, and coagulation. This is an in vivo (within the living body) procedure, not an in vitro test.
The information provided describes a surgical laser device, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
- C02 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, 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.
Product codes
GEX, ONG
Device Description
The Ilooda Fraxis CO2 Laser is comprised of the following major components:
- The main console unit
- Delivery handpieces (2)
- Footswitch.
- Accessories
The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
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
Medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
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)
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
In addition, software verification and validation testing was performed and biocompatibility was established.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160312 Fraxis Duo
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2017
Ilooda Co. LTD % Ms. Kathy Maynor Emvera Technologies, LLC 641 10th St Cedartown, Georgia 30125
Re: K172096
Trade/Device Name: Ilooda Fraxis CO2 Laser 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, ONG Dated: July 10, 2017 Received: July 11, 2017
Dear Ms. Maynor:
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 Actinclude 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.
Jennifer R. Stevenson -S3
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) K172096
Device Name Ilooda Fraxis CO2 Laser
Indications for Use (Describe)
- C02 LASER Part:
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, 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.
| 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 PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 8 – 510(k) Summary or 510(k) Statement
I. General Information [21 CFR 807.92(a) (1)]
| Submitter: | Ilooda
120, Jangan-Ro 458 Beon-Gil
Jangan-Gu
Suwon-Si Gyeonggido, KOREA, REPUBLIC OF
16200 | |
|---------------------------|--------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Kathy Maynor
Consultant
352-586-3113 (cell)
Kmaynor77@gmail.com | |
| Summary Preparation Date: | August 9, 2017 | |
II. Names [21 CFR 807.92 (a) (2)]
| Device Names: | The Ilooda Fraxis CO2 Laser |
|---|---|
| Primary Classification Names: | Surgical Powered Light Instrument, |
| Regulation No.: | 21 CFR 878.4810 |
| Device Regulation Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Product Code: | GEX, ONG |
| Device Class: | II |
Predicate Devices [21 CFR 807.92(a) (3)] III.
| K # | Predicate Device |
|---|---|
| K160312 | Fraxis Duo |
IV. Product Description [21 CFR 807.92(a) (4)]
The Ilooda Fraxis CO2 Laser is comprised of the following major components:
- The main console unit 1.
-
- Delivery handpieces (2)
-
- Footswitch.
-
- Accessories
4
The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
V. Indications for Use [21 CFR 807.92(a) (5)]
- 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.
VI. Summary of Technical Characteristics Compared to Predicate [21 CFR 807.92(a)(6)]
Table 1: Salient Characteristics of the Ilooda Fraxis CO2 Laser and the Predicate Device
| Characteristic | K172096
Ilooda Fraxis CO2 Laser | K160312
Fraxis Duo |
|----------------------------------------------------------|----------------------------------------|----------------------------------------|
| Product Code & | GEX, ONG | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Laser Type | CO2 | CO2 |
| Laser wavelength | 10.6µm | 10.6µm |
| Output power | 30W | 30W |
| Pulse Duration | 20-5,000µs | 20-5,000µs |
| Fractional Pulse energy | Max 150mJ | Max 150mJ |
| Repetition rate | 1,000Hz | 1,000Hz |
| Scan area | 20x20mm | 20 x 20mm |
| Spot size | 100-200µm
Non-fractional: Max 1.3mm | 100-200µm
Non-fractional: Max 1.3mm |
| Number of microbeams
per surface area
(fractional) | Max 289 spot/cm2 | Max 289 spot/cm2 |
| Energy per microbeam
(fractional) | 150mJ | 150mJ |
| Total power per surfaced
area (fractional) | Max 30W | Max 30W |
| Treatment Time | 10-15 min | 10-15 min |
| Pulse rate (non-
fractional) | 1Hz - 1,000Hz | 1Hz - 1,000Hz |
5
| Pulse width (non-
| fractional) | 20μs – 5000μs | 20μs – 5000μs |
|---|---|---|
| Operational mode | Fractional mode, normal mode | |
| (CW, Pulse, Single Pulse) | Fractional mode, surgical | |
| mode (CW, pulsed, single | ||
| pulse) | ||
| Aiming beam | Diode laser(Red), Max 4mW | Diode laser(Red), Max 4mW |
| Cooling | Air cooling | Air cooling |
| User Interface | LCD touch screen | LCD touch screen |
| Optical guide | Articulated arm | Articulated arm |
| Electrical Requirements | 100-240VAC, | |
| 50-60 Hz, | ||
| 6.3 A, | 100-240VAC | |
| 50-60 Hz | ||
| 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. | - 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 |
VII. Differences Between the Fraxis and Fraxis Duo
The Fraxis does not have the RF micro-needling handpiece named GynoLase, so they are not included in the equivalence chart above. These handpieces are included in the Fraxis Duo, the predicate device.
Performance Testing [21 CFR 807.92(b)(1)] VIII.
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
6
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment IEC 60825-1Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
In addition, software verification and validation testing was performed and biocompatibility was established.
IX.. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject, primary predicate and reference devices, no clinical studies were deemed needed to support this submission.
X. Conclusion
The Ilooda Fraxis CO2 laser was found to be substantially equivalent to the predicate devices.
The Ilooda Fraxis CO2 laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.