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 CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

Device Description

The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm.

The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located.

The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, articulated arm with CO2 scanner, the control electronics.

The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

AI/ML Overview

This submission describes a medical device, the YOULASER CO2 laser system, seeking 510(k) clearance. The device is a Class II laser surgical instrument for use in general and plastic surgery and dermatology. It operates in both traditional (non-fractionated) and fractionated modes.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantifiable acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance evaluation is described qualitatively as "safety and effectiveness" and "ablation, coagulation depth and the healing evolution of the skin at the typical settings of use of Youlaser CO2."

Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The overall acceptance criterion is "substantial equivalence" to the predicate devices. The reported device performance is that it was found to be "as safe as effective as the predicated devices" based on the described non-clinical testing.
Sample Size Used for the Test Set and Data Provenance:

The document mentions a "specific non clinical testing was conducted on the proposed YOULASER CO2 device." However, it does not provide details about the sample size used for this test set.

Regarding data provenance, the testing was conducted on the "proposed YOULASER CO2 device," implying this was a prospective study using the actual device. The country of origin of the data is not explicitly stated, but the applicant/manufacturer is Quanta System SPA, based in Italy.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth for the non-clinical testing. The assessment of "ablation, coagulation depth and the healing evolution of the skin" would likely be through objective measurements and potentially histological analysis rather than expert consensus on subjective outcomes.
Adjudication Method for the Test Set:

Since no experts are mentioned for establishing ground truth, there is no adjudication method described. The non-clinical testing appears to be based on objective measurements related to the laser's effects on tissue.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device in question is a surgical laser, not an imaging diagnostic tool that would typically involve multiple readers interpreting cases. The testing described is non-clinical and assesses direct tissue interaction.
Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical surgical laser, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.
Type of Ground Truth Used:

The "ground truth" for the non-clinical testing appears to be based on objective measurements of tissue response to the laser parameters. This includes "ablation, coagulation depth and the healing evolution of the skin." This would involve direct physical or biological measurements/observations, likely including histological analysis, rather than expert consensus on a subjective interpretation, pathology of a disease state, or patient outcomes data in an extensive clinical trial setting.
Sample Size for the Training Set:

Since this is a physical medical device and the testing focuses on its physical effects rather than an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned.
How the Ground Truth for the Training Set Was Established:

As the concept of a "training set" for an AI algorithm is not applicable, there is no information on how ground truth for a training set was established.

Summary

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K 123573

510(K) SUMMARY

APR 1 5 2013

Introduction:

This document contains the 510(k) Summary for the YOULASER CO2 laser system.

The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant /ManufacturerName and Address:	Quanta System SPAVia IV Novembre, 116Solbiate Olona (VA)Italy, 21058
510(k) Contact Person:	Maurizio BianchiRegulatory Affairs ManagerQuanta System SPA
	Email: Maurizio.bianchi@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	November 16th, 2012
Device Name:	YOULASER CO2
Classification:	Class II
Classification Name:	Laser surgical instrument for use in generaland plastic surgery and in dermatology
Regulation Number:	21 CFR 878.4810
Product Code:	GEX

Predicate Devices:

The YOULASER CO2 Laser System is claimed to be substantially equivalent to the following legally marketed predicate devices:

Lutronic Corp - MOSAIC e CO2 (K080496)
Lutronic Corp - MOSAIC e CO2 (K091115)
Lasering Srl - SLIM Evolution Family (K063001)
Lasering Srl - SLIM Evolution II Family (K110984)
El.En S.p.A - Smart CO2 Laser System (K072159)

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Performance Standards:

There are no mandatory performance standards for this device.

A specific investigation to evaluate the safety and the effectiveness has been planned and performed :

A specific non clinical testing was conducted on the proposed YOULASER CO2 device to support a determination of substantial equivalence

The testing has evaluated the ablation, coagulation depth and the healing evolution of the skin at the typical settings of use of Youlaser CO2.

In conclusion the results of these tests provided reasonable assurance that the YOULASER CO2 is as safe as effective as the predicated devices and support a determination of substantial equivalence.

General Device Description:

The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm.

The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, articulated arm with CO2 scanner, the control electronics.

The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

Indications for Use:

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 CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

Comparison of Technological Characteristics:

The laser specifications for the YOULASER CO2 laser system are substantially equivalent to the laser specifications for its identified predicate device with respect to the laser source, wavelengths, maximum energy, spot size, fluence,

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pulse width, repetition rate, beam delivery, power monitor, actuator, and aiming beam.

Comparison of Intended Use:

The intended use of the YOULASER CO2 laser system is the same as the intended use of its previously cleared devices.

Substantial Equivalence:

The Quanta System YOULASER CO2 laser system is as safe and effective as the predicate devices.

The YOULASER CO2 laser system has the same intended use and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the YOULASER CO2 laser system and its predicate devices raise no new issues of substantial equivalence or safety and effectiveness.

Thus, the YOULASER CO2 laser system is substantially equivalent to its identified predicate devices.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 15, 2013

Quanta System, S.P.A. % Mr. Maurizio Bianchi Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058

Re: K123573 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: March 8, 2013 Received: March 11, 2013

Dear Mr. Bianchi:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Maurizio Bianchi

forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, FOR

Peter D. Ruimm -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123573

Device Name: YOULASER CO2

Indications for Use:

YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.04.105 09:32:07 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123573

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Indications for Use Statement

510(k) Number (if known): K123573

YOULASER CO2 Device Name:

Indications for Use:

YOULASER CO2 laser when used in traditional, non fractionated mode is indicated for:

YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

Prescription Use X Use (Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

Over-The-Counter

(Please Do Not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR

Peter D. Rumm, 2013.04.15 -04'00'

(Division Sign-Off) for MXM Neil R. Ogden, M.S. Chief, General Surgery Devices Branch I Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Regulation Number and Section

§ 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.