(121 days)
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No
The document describes a standard diode laser system for hair removal and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for hair removal and permanent hair reduction, which are medical procedures that alter a bodily function, fitting the definition of a therapeutic device.
No
The device is a diode laser system intended for dermatologic and general surgical procedures, specifically for hair removal and permanent hair reduction. It is a therapeutic device, not a diagnostic one, as it changes the body rather than identifying a condition.
No
The device description explicitly details hardware components such as a console, handpiece, umbilical cord, footswitch, diode laser, and cooling system, indicating it is a physical medical device, not software-only.
Based on the provided information, the Speed 808 Diode Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures," specifically "hair removal, permanent hair reduction." This involves direct interaction with the patient's body for a therapeutic or cosmetic purpose.
- Device Description: The description details a laser system with a handpiece that is "pressed against the patient's skin" to deliver energy. This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The Speed 808 Diode Laser System does not perform this function. It applies energy to the body.
Therefore, the Speed 808 Diode Laser System is a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
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.
Product codes
GEX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows a logo for "TOPLASER". The logo consists of a stylized graphic above the text. The graphic is a dark, abstract shape that resembles a stylized sun or a partial circle with curved edges. The text "TOPLASER" is in a bold, sans-serif font, positioned directly below the graphic.
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
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
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Date Prepared: Dec. 20, 2013
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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
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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
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Predicate Device
Modified Alma Lasers Family of Soprano XL™ Multi- Application Platforms [Soprano XL, Soprano XLi] ( K102716) Manufactured by Alma Lasers, INC.
- 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
ર- I
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
1
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 .
5-2
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 .
2
Non-Clinical Conclusion:
ﻣ ﺖ
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
Image /page/5/Picture/10 description: The image shows the text "Neil R" on the top left corner. Below it, the date "2014.01.21" is visible, followed by the time "13:38:13:05'00'". The text is slightly blurred, and there are some symbols in the middle of the text.
(Division Sign-Off) for BSA
Division of Surgical Devices
K132989 510(k) Number_