(22 days)
Not Found
No
The summary describes a standard CO2 laser device for soft tissue ablation and skin resurfacing. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on electrical and laser safety standards.
Yes
The device is used for medical procedures like incision, excision, ablation, and vaporization of soft tissues, which are therapeutic interventions. Additionally, its use in "surgical" and "therapeutic" laser equipment standards further confirms its therapeutic nature.
No
The device description and intended use clearly state that it is a surgical laser device for incision, excision, ablation, and vaporization of soft tissues, and for ablative skin resurfacing. None of these functions are diagnostic in nature.
No
The device description explicitly states it is a "CO2 laser device" with a "CO2 laser source" and "articulated arm," indicating it is a hardware device that emits a laser beam.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for surgical procedures (incision, excision, ablation, vaporization) on body soft tissues. This is a direct treatment of the patient's body.
- Device Description: The device is a CO2 laser, which is a therapeutic device used to interact with tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly a surgical laser intended for direct treatment of the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, 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)
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.
- 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.
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.
Not Found
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/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
1
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 /
Manufacturer
Name and Address: | Quanta System SPA
Via Acquedotto, 109
21017 Samarate (VA)
Italy |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SpA
Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +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 surgery
and 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.