The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

Device Description

The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.

The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.

The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Q-Switched Nd:YAG Laser System:

Based on the provided 510(k) summary, the device is a Q-Switched Nd:YAG Laser System. The submission is for a medical device and therefore the acceptance criteria are not clinical performance metrics but rather compliance with design specifications and regulatory standards.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standards and Regulations)	Reported Device Performance
Safety and Performance	- IEC 60825-1: 2007 (Safety of laser products - Part 1: Equipment classification, requirements and user's guide) - IEC 60601-2-22:1995 (Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) - IEC 60601-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment - Part 1: General requirements for safety)	"Laboratory testing was conducted to validate and verify that the proposed device Q-Switched Nd: YAG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device." The submission asserts that the device is designed, tested and will be manufactured in accordance with these standards, implying it meets them.
Electromagnetic Compatibility (EMC)	- IEC60601-1-2:2001+A1:2004 (Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests)	"The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification."
Regulatory Compliance	- European Medical Device Directive 93/42/EEC - US Federal Performance Standards 21 CFR 1002.10 (including 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products) - 21 CFR Part 820 (Quality System Regulation) - ISO9001 and ISO13485 System Certification	The document explicitly states: "The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification."
Substantial Equivalence	Demonstrating substantial equivalence to the predicate device (Spectra VRMII, K073436) in terms of indications for use, safety, design, and functional features.	"The Q-Switched Nd: YAG Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, Spectra VRMII (O-Switched Nd:YAG) (K073436)." "In addition, a review of the predicate device demonstrates that the O-Switched Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device."

Study Information

Sample size used for the test set and the data provenance:
- The provided text does not mention any clinical test set involving human subjects or data. The testing discussed is non-clinical laboratory testing to verify design specifications and compliance with standards.
- The "data provenance" mentioned is compliance with international standards (IEC) and national regulations (US FDA, EU MDD).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as there is no clinical test set described in the provided document. The "ground truth" for this submission focuses on engineering specifications and regulatory compliance.
Adjudication method for the test set:
- This information is not applicable as there is no clinical test set described.
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:
- No, an MRMC comparative effectiveness study was not done. This document describes a laser system, not an AI-assisted diagnostic device, and therefore this type of study is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical laser system, not an algorithm. The "standalone performance" refers to the device's ability to meet its technical specifications and regulatory requirements.
The type of ground truth used:
- For this 510(k) submission, the "ground truth" is defined by established engineering design specifications, international performance and safety standards (e.g., IEC standards), and national/regional medical device regulations (e.g., 21 CFR, MDD). The device's performance against these specifications and standards constitutes the "ground truth" for its safety and effectiveness determination via substantial equivalence.
The sample size for the training set:
- This information is not applicable as there is no discussion of a training set for an algorithm. The device is a physical laser system.
How the ground truth for the training set was established:
- This information is not applicable as there is no discussion of a training set for an algorithm.

Summary

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Section III. 510(K) Summary

JUL 2 5 2010

Q-Switched Nd:YAG Laser System Advanced Technology Laser Co., Ltd

(As required by 21 CFR 807.92)

1. Date Prepared: March 22, 2010

2. Sponsor Information:

Advanced Technology Laser Co., Ltd 920 Jian-chuan Road, Bldg. A2, Level 5 Shanghai, 200240, China

Contact Person: Mingxia Xi, Director for Regulatory Affairs Phone: +86-21-54712151 Fax: +86-21-54712152

3. Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: +86-21-64264467-809 Email: Diana.hong@mid-link.net

1. Proposed Device Information

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DVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary Device Common or Usual Name: O-Switched Nd: YAG Device Trade or Proprietary Name: Q-Switched Nd: YAG Laser System Model: GlobalCure-SC6 Classification Name: Laser Instrument, Surgical, Powered; Regulation Number: 21 CFR 878.4810; Product Code: GEX Panel: 878 General and Plastic Surgery

5. Predicate Device

Spectra VRMII (O-Switched Nd: YAG) (K073436)

6. Device Description

The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

7. Indications for use

532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions

Removal of Minor Vascular Lesions

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VANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary

Treatment of Lentigines

Treatment of Caf6-Au-Lait

Treatment of Seborrheic Keratoses

Treatment of Post Inflammatory Hyper-Pigmentation

Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos

Removal of Nevus of Ota

Removal of lightening of unwanted hair with or without adjuvant preparation

Treatment of Common Nevi

Skin resurfacing procedures for the treatment of acne scars and wrinkles

8. Substantial Equivalence

The Q-Switched Nd:YAG Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, Spectra VRMII (O-Switched Nd:YAG) (K073436). In addition, a review of the predicate device demonstrates that the O-Switched Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.

9. Testing

The Q-Switched Nd: YAG Laser System (GlobalCure-SC6) is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
. IEC 60601-2-22:1995, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
0 IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary

IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests.

The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification.

Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verity that the proposed device Q-Switched Nd: Y AG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style.

Public Health Service

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

Advanced Technology Laser Co., Ltd. % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747

Received: July 21, 2010

UUL Z 5 2010

Re: K102050

Trade/Device Name: Q-Switched 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: II Product Code: GEX Dated: July 9, 2010

Dear Mr. Conry:

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

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Page 2 - Ms. Julie Acker, RAC

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 tc

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 vours.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -Indications for Use Statement

K102050

Section II. Indications for Use Statement

JUL 2 9 2010

510(k) Number:

Device Name:

Q-Switched Nd: YAG Laser System

Indications for Use:

532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos

Removal of Epidermal Pigmented Lesions

Removal of Minor Vascular Lesions

Treatment of Lentigines

Treatment of Caf6-Au-Lait

Treatment of Seborrheic Keratoses

Treatment of Post Inflammatory Hyper-Pigmentation

Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos

Removal of Nevus of Ota

Removal of lightening of unwanted hair with or without adjuvant preparation

Treatment of Common Nevi

Skin resurfacing procedures for the treatment of acne scars and wrinkles

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

Page 1 of 1

11-1

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices

K102054

510(k) Number

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.