SPEED 808 DIODE LASER SYSTEM

K132989 · Beijing Toplaser Technology Co., Ltd. · GEX · Jan 23, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132989
• Device Name: SPEED 808 DIODE LASER SYSTEM
• Applicant: Beijing Toplaser Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Speed 808 Diode Laser System is a surgical laser instrument for dermatology. System comprises a console, footswitch, and handpiece connected via umbilical cord. Handpiece contains a diode laser and a 10mm x 10mm sapphire aperture. Device operates by pressing the sapphire aperture against patient skin and delivering laser pulses via handpiece trigger or footswitch. Integrated cooling system protects skin during treatment. Clinician controls laser parameters via console LCD screen and buttons. Device provides permanent hair reduction by targeting hair follicles. Intended for use in clinical settings by trained professionals.

Clinical Evidence

Bench testing only. No clinical data required.

Technological Characteristics

Diode laser source; 10mm x 10mm sapphire aperture; integrated cooling system; console-based control with LCD interface; footswitch activation. Complies with IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, and UL 60601-1.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

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.

Predicate Devices

• Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] (K102716)

Submission Summary (Full Text)

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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

1. Date Prepared: Dec. 20, 2013

2. 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: [phone] Fax: [phone]

3. 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

4. Predicate Device

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

5. 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

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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: [e-mail] Tel: [phone]

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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: [e-mail] Tel: [phone] .

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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: [e-mail] Tel: [phone]

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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

1. 1. 1. 1. 1. 1. 1. 1. 1. 1.

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 [phone] or [phone] 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 [phone] or [phone] 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_