· Tattoo Removal
· Treatment of Vascular Lesions
· Treatment of Pigmented Lesions,
· Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

1064nm:
Tattoo Removal: Dark ink: blue and black
Treatment of Pigmented Lesions: Nevus of ota

532nm:
Tattoo Removal: Light ink: red, Light ink: sky blue and green
Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi
Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus

Device Description

The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.

Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Nd: YAG Laser System (Qmetrx 1000 (Victory 11)) and assesses its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria related to device performance in a clinical context (e.g., efficacy rates for tattoo removal, lesion clearance), nor does it detail a study proving the device meets such criteria through clinical endpoints.

Instead, the document focuses on non-clinical testing to ensure safety and compliance with recognized standards.

Here's an analysis of the provided information, addressing your questions based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific performance acceptance criteria (e.g., target percentages for lesion clearance or tattoo fading) or a report of the device's clinical performance against such criteria. The "Testing" section focuses on compliance with international safety and electrical standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Compliance
Safety and Electrical	IEC 60825-1 (Laser Safety)	Met
	IEC 60601-2-22 (Therapeutic Laser Safety)	Met
	IEC 60601-1 (General Safety)	Met
	IEC 60601-1-2 (EMC)	Met
	UL 60601-1:2003 R6.03 (Electrical Safety)	Met
Design Specifications	All design specifications	Met
Substantial Equivalence	Similar indications for use, design, features, safety compliance to predicate devices (K014234, K011677)	Determined by FDA

2. Sample size used for the test set and the data provenance

The document explicitly states: "No Clinical Information is required." Therefore, there was no clinical test set in the traditional sense of patient data. The testing mentioned refers to laboratory testing for safety and design specifications. There is no information about data provenance (country of origin, retrospective/prospective) for a clinical test set because none was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical test set was used, no experts were utilized to establish ground truth for a clinical test set. The grounding of the device's safety and effectiveness relies on compliance with engineering standards and comparison to previously approved predicate devices by the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

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 system, not an AI-based diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (laser system), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was established by adherence to the specified international and national safety and performance standards (e.g., IEC 60825-1, IEC 60601 series, UL 60601-1). The device's "effectiveness" from the perspective of this 510(k) is primarily established through its substantial equivalence to the predicate devices, which means it shares similar indications for use, design, and functional features, implying similar efficacy outcomes based on the predicate's established history.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set.

Summary

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FEB 2 8 2014

510(k) Summary

Nd: YAG Laser System Beijing Toplaser Technology Co., Ltd. (As required by 21 CFR 807.92) K Number: K133158

Date Prepared: Sep. 22, 2013
Sponsor Information Beijing Toplaser Technology Co., Ltd. East 30 Floor, Building M7, No.1 Jiuxianqiao East Road, Chaoyang District, Beijing 100015, China Contract Person: Zhang Xiaosong, General Manager Phone: +86-10-64354759 Fax: +86-10-64356591
Proposed Device Information Device Common or Usual Name: Nd: YAG Laser Device Trade or Proprietary Name: Qmetrx 1000 (Victory 11) Nd: YAG Laser System Classification Name: Laser instrument, Surgical, Powered Regulation Number: 21 CFR 878.481 0 Product Code: GEX Panel: General and Plastic Surgery Model: QMetrx1000 (Victory-11)
Predicate Device Medlite C6 Q-Switched Nd: YAG Laser (K014234) Medlite™ C3 Q-Switched Nd: YAG Laser (K011677) Manufactured by Continuum Electro-Optics, Inc.

5. Device Description

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Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.

Intended use and Indications of Use

· Tattoo Removal
· Treatment of Vascular Lesions
· Treatment of Pigmented Lesions,

• Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

1064nm	532nm
Tattoo Removal	Tattoo Removal
Dark ink: blue and black	Light ink: red Light ink: sky blue and green
Treatment of Pigmented Lesions	Treatment of Vascular Lesions
Nevus of ota	Port wine birthmarks Telangiectasias Spider angioma Cherry angioma Spider nevi
	Treatment of Pigmented Lesions
	Café-au-lait birthmarks Solar lentiginos Senile lentiginos Becker's nevi Freckles Nevus spilus

7. Substantial Equivalence

The product Nd:YAG Laser System, model QMetrx1000(Victory-11) shares the similar indications for use, design features, functional features, same safety compliance. Therefore the product Nd:YAG Laser System, model

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QMetrx1000(Victory-11) is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

8. Testing

The Nd: YAG Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60825-1: Safety of laser products - Part 1: Equipment classification, . requirements and user's quide.

IEC 60601-2-22: Medical Electrical Equipment - Part 2: Particular . requirements for the safety of diagnostic and therapeutic laser equipment.

IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements . for safety.

IEC 60601-1-2: Medical Electrical Equipment -Part 1: General requirements . for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

UL 60601-1:2003 R6.03 .

Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verify' that the proposed device, QMetrx1000(Victory-11) Nd: YAG Laser System met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 28, 2014

Beijing Toplaser Techonology Company, Ltd. Mr. Zhang Xiaosong General Manager East 3rd Floor, Building M7, No. 1 Jiuxianqiao East Road Chaoyang District, Beijing 100015 CHINA

Re: K133158

Trade/Device Name: Ometrx 1000 (Victory 11) Nd: YAG 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: November 28, 2013 Received: December 2, 2013

Dear Mr. Xiaosong:

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

{4}------------------------------------------------

Page 2 - Mr. Zhang Xiaosong

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 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 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,

Felipe Aguel

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K133158

Device Name: Qmetrx 1000 (Victory 11) Nd: YAG Laser System Indications For Use:

· Tattoo Removal
· Treatment of Vascular Lesions
· Treatment of Pigmented Lesions,
· Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

1064nm	532nm
Tattoo Removal	Tattoo Removal
● Dark ink: blue and black	● Light ink: red
	● Light ink: sky blue and green
Treatment of Pigmented Lesions	Treatment of Vascular Lesions
● Nevus of ota	● Port wine birthmarks
	● Telangiectasias
	● Spider angioma
	● Cherry angioma
	● Spider nevi
	Treatment of Pigmented Lesions
	● Café-au-lait birthmarks
	● Solar lentiginos
	● Senile lentiginos
	● Becker's nevi
	● Freckles
	● Nevus spilus

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use YES (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Felipe Aguel Date: 2014.02.28
14:20:51 -05'00'

(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.