(79 days)
YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars
The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device
The YOULASER CO2 Laser System includes 1 model: YOULASER CO2 with Wavelength 10.6μm and Laser Power 30W. 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, arm with CO2 scanner, the articulated control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.
The provided text is a 510(k) summary for the Quanta System YOULASER CO2. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not present. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics that meet defined acceptance criteria. The statement "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices" is a general claim of equivalence, not a report of specific performance against numerical acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "as safe and effective as the predicate devices" |
2. Sample sized used for the test set and the data provenance:
No dedicated clinical or performance test set data is described. The 510(k) summary structure for this device does not include such a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no dedicated test set requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no dedicated test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for device performance is described. The ground for "substantial equivalence" is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
Not applicable, as this is a hardware device (laser surgical instrument) and not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a hardware device and does not involve a training set.
Summary of what the document does state regarding acceptance and proof:
The document states:
- "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices."
- "The YOULASER CO2 has the same intended uses and similar indications, technological characteristics, and principles of operation As its predicate device."
- "The minor technological differences between the YOULASER CO2 and its predicate devices raise no new issues of safety or effectiveness."
- "Thus, the YOULASER CO2 is substantially equivalent."
The proof that the device meets "acceptance criteria" (which in this context is "substantial equivalence") comes from a comparison of its technological characteristics, intended uses, and indications for use to the predicate devices (El.En S.p.A Smart CO2 Laser System (K072159)). The document explicitly states "Performance Data: None" under the Substantial Equivalence section, indicating that no separate performance studies were conducted or provided to demonstrate novel criteria. The acceptance is based on the argument that the new device is fundamentally similar to an already cleared device, implying that the established safety and effectiveness of the predicate device extends to the new device due to these similarities.
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AUG 25 2011
K111592
510(k) SUMMARY Quanta System YOULASER CO2 Title:
Submitter:
! .
Quanta System SpA via IV Novembre, 116 Solbiate 21058 Olona VA / Italy
Contact:
Maurizio Bianchi Regulatory Affairs Manager
Date Prepared: July 19th, 2011
Quanta System YOULASER CO2 Device Trade Name:
Laser surgical instrument for use in general surgery and Common Name: dermatology
Classification Name: Instrument, surgical, powered, laser
Predicate Devices: - El.En S.p.A Smart CO2 Laser System (K072159);
YOULASER CO2 Laser is indicated for Use incision. Intended excision, ablation, vaporization and coagulation of body Indications for Use: soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic otolaryngology surgery). (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars
The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.
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The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device
Technological Characteristics:
The YOULASER CO2 Laser System includes 1 model :
| Models | Wavelength | Laser Power |
|---|---|---|
| YOULASERCO2 | 10.6μm | 30W |
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, arm with CO2 scanner, the articulated control electronics.
The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.
Performance Data
Substantial Equivalence:
None
The Quanta System YOULASER CO2 is as safe and effective as the predicate devices. The YOULASER CO2 has the same intended uses and similar indications, technological characteristics, and principles of operation The minor technological as its predicate device. differences between the YOULASER CO2 and its predicate devices raise no new issues of safety or YOULASER effectiveness. Thus, the CO2 is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized eagle or bird, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
AUG 25 2011
Re: K111592
Trade/Device Name: Youlaser CO2 Laser System 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: August 11, 2011 Received: August 12, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection b re(i) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encreative to regars) at the Medical Device Amendments, or to commerce phor to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices may nave been results in assee approval of a premarket approval application (PMA). alle Cosment Act (7tel) that do not required to the general controls provisions of the Act. The r ou may, therefore, manel of the Act include requirements for annual registration, listing of gencial controls provisions of vactice, labeling, and prohibitions against misbranding and uevices, good minimaturaling pratised, mot evaluate information related to contract liability additeration. Thease note: ODTCT access as 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 If your device is classified (000 acre) axisting major regulations affecting your device can be fillay be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualic of a substition with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination in a your arries by other Federal agencies. You must or any Federal statures and regulations administed to: registration and listing (21
comply with all the Act's requirements, including, but not seconding of medical comply with all the Act s requirements, included device reporting (reporting of medical
CFR Part 807); labeling (21 CFR Parts and CFR Part 807); labeling (21 CFR 801); incural active rupos mores practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice require device-related adverse evenis) (2) CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, 1000-10 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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
r (1580) htm for and and and and and and 110ffices/usmal 15809 hm for If you desire specific advice to: your acvice of var siconny of the sales of contributions of Commission go to http://www.rda.gov/Abouti DAVCchiersOnecessor sompliance. Also, please
the Center for Devices and Radiological Health's (CDBH) securerlyst notifiestion" (21) CFR Part the Center for Devices and Radiological reality of the entremarket notification" (21 CFR Part
note the regulation entitled, "Misbranding by reference under the MDR regulation note the regulation entilled, "Misolanding of reference to promises
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), piease go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office IIII) .//www.raa.governman.governmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your respectives.
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 (800) 038-2041 of (501) 770 - Frices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milkeran
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 592 510(k) Number (if known):
Device Name: YOULASER CO2
Indications for Use:
YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application:
Dyschromia,
Atrophic + Acne scars, Hypertrophic scars
The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device
Nil RP Ogden for mxm
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K111592
Prescription Use X Use (Part 21 C.F.R. 801 Subpart D) Over-The-Counter
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.