(29 days)
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.
The Ilooda Fraxis CO2 Laser is comprised of the following major components:
- The main console unit 1.
-
- 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.
- Accessories
The provided text details a 510(k) premarket notification for the Ilooda Fraxis CO2 Laser, showing its substantial equivalence to a predicate device (Fraxis Duo). However, the document does not contain any information about acceptance criteria, device performance testing against specific clinical endpoints, or related studies (such as MRMC, standalone, or ground truth establishment) typically associated with AI/ML-driven medical devices.
The performance testing section (VIII) only lists general safety and electrical standards (e.g., IEC 60601-1, IEC 60601-2-22) and mentions software verification/validation and biocompatibility. Crucially, Section IX explicitly states:
"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."
This indicates that the device's approval was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than on demonstrating performance against specific clinical acceptance criteria in a dedicated study. The information required in your request, such as acceptance criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, and detailed ground truth establishment, is typically associated with a more rigorous clinical validation process for novel devices or AI/ML components, which was not performed or submitted for this particular 510(k).
Therefore, I cannot fulfill your request for the specific details within the given document because the document does not contain that information.
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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
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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.
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
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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)
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Section 8 – 510(k) Summary or 510(k) Statement
I. General Information [21 CFR 807.92(a) (1)]
| Submitter: | Ilooda120, Jangan-Ro 458 Beon-GilJangan-GuSuwon-Si Gyeonggido, KOREA, REPUBLIC OF16200 | |
|---|---|---|
| Contact Person: | Kathy MaynorConsultant352-586-3113 (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 plasticsurgery 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
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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 | K172096Ilooda Fraxis CO2 Laser | K160312Fraxis 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 | 100-200µmNon-fractional: Max 1.3mm | 100-200µmNon-fractional: Max 1.3mm |
| Number of microbeamsper surface area(fractional) | Max 289 spot/cm2 | Max 289 spot/cm2 |
| Energy per microbeam(fractional) | 150mJ | 150mJ |
| Total power per surfacedarea (fractional) | Max 30W | Max 30W |
| Treatment Time | 10-15 min | 10-15 min |
| Pulse rate (non-fractional) | 1Hz - 1,000Hz | 1Hz - 1,000Hz |
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| Pulse width (non-fractional) | 20μs – 5000μs | 20μs – 5000μs |
|---|---|---|
| Operational mode | Fractional mode, normal mode(CW, Pulse, Single Pulse) | Fractional mode, surgicalmode (CW, pulsed, singlepulse) |
| 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, | 100-240VAC50-60 Hz |
| Indications for Use | - CO2 LASER Part:Fractional mode is indicatedonly for ablative skinresurfacing.Non-fractional mode isindicated for incision, excision,ablation, vaporization andcoagulation of body soft tissuesincluding intraoral tissues, inmedical specialties includingaesthetic (dermatology andplastic surgery),otorhinolaryngology (ENT),gynecology, neurosurgery,dental and oral surgery andgenitourinary surgery. | - CO2 LASER Part:Fractional mode is indicatedonly for ablative skinresurfacing.Non-fractional mode isindicated for incision,excision, ablation,vaporization and coagulationof body soft tissuesincluding intraoral tissues, inmedical specialties includingaesthetic (dermatology andplastic surgery),otorhinolaryngology (ENT),gynecology, neurosurgery,dental and oral surgery andgenitourinary surgery.- HF electrosurgical Part: TheFRAXIS DUO is intended foruse in dermatologic andgeneral surgical procedures forelectro-coagulation andhemostasis |
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
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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.
§ 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.