(22 days)
When used in traditional, non-fractionated mode for:
Incision, excision, ablation, vaporization 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.
When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
YOULASER CO2 laser device has a CO2 laser source emitting at 10600 nm. The beam delivery is enabled through an articulated arm.
Emission is triggered by means of the footswitch or the finger switch available on the scanner.
The provided text is a 510(k) summary for the Quanta System SpA Youlaser CO2 device. This document focuses on the regulatory clearance process for a medical device and describes modifications made to an already cleared device. It details the performance testing related to electrical safety, electromagnetic compatibility, and general laser safety standards.
However, the document does not contain information related to the clinical performance of the device in terms of acceptance criteria for a specific medical condition, a clinical study proving such criteria are met, or details about ground truth establishment, expert adjudication, or AI performance metrics.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.
The document states:
- Performance Standards: "There are no mandatory performance standards for this device."
- Performance Testing: "The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances: IEC 60601-1:2005 + AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-22:2007 + AMD1:2012, IEC 60825-1: 2014. The subject device passed all the required testing and complicable sections of the above-mentioned standards."
This indicates that the performance testing was engineering-focused (electrical, safety, EMC) rather than clinical efficacy or effectiveness for a specific clinical outcome.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
Quanta System SpA Francesco Dell'antonio Vice President, Regulatory Affairs and QA Via Acquedotto 109 Samarate, 21017 It
October 17, 2018
Re: K182669
Trade/Device Name: Youlaser CO2 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 Dated: September 10, 2018 Received: September 25, 2018
Dear Francesco Dell'antonio:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820)
for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R Ogden -S 2018.10.17 08:47:17 -04'00' 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Youlaser CO2
Indications for Use (Describe)
When used in traditional, non-fractionated mode for:
Incision, excision, ablation, vaporization 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.
When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) SUMMARY
| Applicant /ManufacturerName and Address: | Quanta System SPAVia Acquedotto, 10921017 Samarate (VA)Italy |
|---|---|
| 510(k) Contact Person: | Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SpAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815 |
| Date Prepared: | 16th October 2018 |
| Brand Names: | Youlaser CO2 |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for Submission: | Device modifications |
| Primary Predicate Device: | Youlaser CO2 (K123573) – Quanta System SpA |
Performance Standards:
There are no mandatory performance standards for this device.
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Device description
YOULASER CO2 laser device has a CO2 laser source emitting at 10600 nm. The beam delivery is enabled through an articulated arm.
Emission is triggered by means of the footswitch or the finger switch available on the scanner.
Description of the modifications:
This Special 510(k) is submitted due to techcnial modifications of the already cleared device.
The device was changed as follows:
- Electronics: an embdedded PC is added to manage the GUI ●
- A prioprietary Scanner - Optiscan - is introduced
- Emission is triggered also from a fingerswitch mounted on the scanner
- Change to the GUI appearance
- . Change to the external panels
Based on the nature of the changes implemented, the device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards.
Intended Use/Indications for Use
The subject device has the same intended use of the unmodified device, as follows:
When used in traditional, non-fractionated mode 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.
When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
Performace testing
The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:
- -IEC 60601-1:2005 + AMD1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- -IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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- ၊ IEC 60601-2-22:2007 + AMD1:2012, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- -IEC 60825-1: 2014 Safety of laser products – Part 1: Equipment classification and requirements
The subject device passed all the required testing and complicable sections of the abovementioned standards.
Comparison with predicate device:
The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Co2 laser sources, with equivalent specifications.
Summary
The subject device is substantially equivalent to its identified 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.