The permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Device Description

Speed 808 Diode Laser System are new devices for 510(k) submission and share the similar indication for use and safety compliance, similar design features and functional features with the predicate devices.

The complete system consists of a console, a handpiece connected to the system by an umbilical cord and a footswitch. There are two important components in the handpiece: a diode laser inserted in the handpiece and a sapphire-made aperture with an area of 10mmX10mm through which laser energy is emitted. A cooling system effectively works on the sapphire-made aperture and can ensure enough and continuous protection of skin. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output, the system requires the activation of the handpiece trigger or the footswitch. Laser specifications and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.

AI/ML Overview

The Speed 808 Diode Laser System is intended for hair removal and permanent hair reduction. The manufacturer states that the device is substantially equivalent to the predicate device, Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms.

Here's a breakdown of the information requested, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for hair removal or permanent hair reduction. Instead, it relies on substantial equivalence to a predicate device.

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Intended Use	"hair removal, permanent hair reduction"	"Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures. The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction."
Permanent Hair Reduction Definition	"long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen"	The device's indication aligns with this definition. No specific performance data (e.g., percentage reduction) is provided.
Skin Types	"intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin"	The device's indication aligns with this. No specific performance data for different skin types is provided.
Safety and Effectiveness	Substantial equivalence to predicate device (Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] (K102716)) in terms of "indications for use, design features, functional features, same safety compliance."	"Speed 808 Diode Laser System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues."
Compliance with Standards	IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, UL 60601-1:2003 R6.03	"Speed 808 Diode Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards..."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No Clinical Information is required." This indicates that no clinical test set with human subjects was used for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical test set was used, there were no experts used to establish a ground truth for a test set. The regulatory body (FDA) reviewed the non-clinical data and the claim of substantial equivalence.

4. Adjudication Method 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

No, an MRMC comparative effectiveness study was not done. The submission did not involve clinical studies with human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a laser system, not an AI algorithm. The testing was non-clinical, focusing on design specifications and compliance with standards.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Engineering and design specifications: The device was tested to meet its design specifications.
Compliance with international and national standards: The device underwent testing to ensure it met relevant safety and performance standards (e.g., IEC, UL).
Substantial equivalence to a legally marketed predicate device: The fundamental "ground truth" for regulatory clearance was the demonstration that the device is as safe and effective as the predicate device already approved for marketing, without raising new issues.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this device does not utilize a training set in the AI sense.

Summary

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JAN 2 3 2014 BEIJING TOPLASER TECHNOLOGY CO., LTD.

5. 510(k) Summary

Speed 808 Diode Laser System Beijing Toplaser Technology Co., Ltd. (As required by 21 CFR 807.92) K Number: K132989

Date Prepared: Dec. 20, 2013
Sponsor Information Beijing Toplaser Technology Co., Ltd. East 3rd 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: diode laser Device Trade or Proprietary Name: Speed 808 Diode Laser System Classification Name: Laser instrument, Surgical, Powered Requlation Number: 21 CFR 878.481 0 Product Code: GEX Panel: General and Plastic Surgery Model: LD-1
Predicate Device

Modified Alma Lasers Family of Soprano XL™ Multi- Application Platforms [Soprano XL, Soprano XLi] ( K102716) Manufactured by Alma Lasers, INC.

Device Description

The complete system consists of a console, a handpiece connected to the

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Add: East 3rd Floor, Building M7, NO.1 Jiuxianqiao East Road, Chaoyang District, Beijing 100015 China Web: www.toplaser.com Mail: office@toplaser.com.cn Tel: +86-10-64354759

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system by an umbilical cord and a footswitch. There are two important components in the handpiece: a diode laser inserted in the handpiece and a sapphire-made aperture with an area of 10mmX10mm through which laser energy is emitted. A cooling system effectively works on the sapphire-made aperture and can ensure enough and continuous protection of skin. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output, the system requires the activation of the handpiece trigger or the footswitch. Laser specifications and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.

6. Intended use/ Indications for Use

The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures.

The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction.

The permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

7. Substantial Equivalence

Speed 808 Diode Laser System shares the similar indications for use, design features, functional features, same safety compliance. Therefore Speed 808 Diode Laser System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

8. Testing

Speed 808 Diode 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 . and Requirements

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 . Standard: Electromagnetic compatibility safety-2, Collateral for Requirements and tests.

UL 60601-1:2003 R6.03 .

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Add: East 3rd Floor, Building M7, NO.1 Jiuxianqiao East Road, Chaoyang District, Beijing 100015 China Web: www.toplaser.com Mail: office@toplaser.com.cn Tel: +86-10-64354759 .

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Non-Clinical Conclusion:

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Laboratory testing was conducted to validate and verify' that the proposed device, Speed 808 Diode Laser System met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required.

Add: East 3rd Floor, Building M7, NO.1 Jiuxianqiao East Road, Chaoyang District, Beijing 100015 China Web: www.toplaser.com Mail: office@toplaser.com.cn Tel: +86-10-64354759

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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 stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.

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

Beijing Toplaser Technology Company, Ltd Mr. Xiaosong Zhang General Manager East Third Floor, Building M7 #1 Jiuxiangquiao East Road Chaoyang District, Beijing 100015 CHINA

January 23, 2014

Re: K132989

Trade/Device Name: Speed 808 diode 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: December 20, 2013 Received: December 26, 2013

Dear Mr. Zhang:

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.

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Page 2 - Mr. Xiaosong Zhang

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 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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Acting Director For 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): K132989 Device Name: Speed 808 Diode Laser System

Indications For Use:

The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures.

The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction.

The permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regiment

The Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

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(Division Sign-Off) for BSA

Division of Surgical Devices

K132989 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.