(252 days)
Not Found
No
The summary describes a standard laser hair removal system with basic functional modules and operating modes, with no mention of AI or ML capabilities.
Yes
The device is described as intended for "dermatologic and general surgical procedures" and is identified by a safety standard (IEC 60601-2-22:2007+A1:2012) that includes "therapeutic" laser equipment. While its primary function is hair removal, which might be considered cosmetic, the mention of surgical procedures and its classification under therapeutic equipment standards indicates it can be used in a therapeutic capacity.
No
The device is described as a "Diode Laser Hair Removal System" intended for hair removal and permanent reduction in hair regrowth. Its functionality is therapeutic (altering hair growth) and surgical, not diagnostic.
No
The device description clearly outlines physical hardware components including a semiconductor diode laser source, a handpiece, a footswitch, a power supply system, a central control system, a cooling system, and a laser delivery system. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "Diode Laser Hair Removal System" intended for "hair removal of unwanted hair, and permanent reduction in hair regrowth." It's a surgical device that applies energy directly to the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is to interact with the body externally.
The device is a therapeutic/surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-V), including tanned skin The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regiment.
Product codes
GEX
Device Description
The diode laser hair removal system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed diode laser removal system has two models. GP900A and GP900O. Both GP900A and GP900Q have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free setting mode. The GP900A is a standard case with wheels to allow easy movement on the floor. The GP900Q is a desktop case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007, Medical Electrical Equipment- Part 1: General requirements for safety.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
IEC 60601-2-22:2007+A1:2012, Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity. ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Shenzhen Gsd Tech. Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K142186 Trade/Device Name: Diode Laser Hair Removal 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: July 29, 2014 Received: August 14, 2014
Dear Diana Hong,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142186
Device Name Diode Laser Hair Removal System
Product Model: GP900A/ GP900Q
Indications for Use (Describe)
The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-V), including tanned skin
The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regiment
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPEETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Exhibit #3 510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Submission: July 29, 2014
-
- Sponsor Identification
Shenzhen GSD Tech Co., Ltd. 703, Building A, Futian TianAn Hi-tech, Venture Park, Shenzhen, Guang Dong, 51804, China
Establishment Registration Number: 3006580954
Contact Person: Wu Liu Position: Registration Engineer Tel: +86-755-82043118 Fax: +86-755-29069786 Email: 1184086173@qq.com
-
- Submission Correspondent
Ms. Diana Hong& Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
4
4. Proposed Device Identification
Proposed Device Name: Diode Laser Hair Removal System Proposed Device Common Name: Laser Hair Removal instrument Product Model: GP900A/ GP900Q
Regulatory Information: Classification Name: Powered Laser Surgical Instrument; Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;
Intended Use Statement:
The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures.
The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair
regrowth.
The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
-
ડ. Predicate Device Identification
510(k) Number: K123483 Product Name: Diode Laser Manufacturer: Beijing Syntech Laser Co., Ltd -
Device Description 6.
The diode laser hair removal system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
5
The proposed diode laser removal system has two models. GP900A and GP900O. Both GP900A and GP900Q have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free setting mode.
The GP900A is a standard case with wheels to allow easy movement on the floor. The GP900Q is a desktop case.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007, Medical Electrical Equipment- Part 1: General requirements for safety.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
IEC 60601-2-22:2007+A1:2012, Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity. ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
6
- Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, energy source and fluency, etc.
| Item | Proposed Device(s) | Predicate Device |
|---|---|---|
| Product model | GP900A | K123483 |
| Product Code | GEX | DLH-06 |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Intended Use | The Diode Laser Hair Removal System is | |
| intended for use in dermatologic and general | ||
| surgical procedures. | ||
| The Fast Mode is intended for hair removal | ||
| of unwanted hair, and permanent reduction in | ||
| hair regrowth. | ||
| The Free Setting Mode is intended for hair | ||
| removal of unwanted hair, and permanent | ||
| reduction in hair regrowth. | ||
| The Diode Laser Hair Removal System is | ||
| intended for use on all skin types (Fitzpatrick | ||
| skin types I-VI), including tanned skin. | ||
| The permanent reduction in hair regrowth is | ||
| defined as long-term, stable reduction in the | ||
| number of hair regrowing when measured at | ||
| 6, 9 and 12 months after the completion of a | ||
| treatment regime. | The Diode Laser is intended for use in | |
| dermatologic and general surgical | ||
| procedures. | ||
| The Standard Mode is intended for hair | ||
| removal, permanent hair reduction. | ||
| The FHR Mode is intended for hair | ||
| removal, permanent hair reduction. | ||
| The Diode Laser Hair Removal System | ||
| is intended for use on all skin types | ||
| (Fitzpatrick skin types I-VI), including | ||
| tanned skin. | ||
| Configuration | Laser system and handpiece | Laser system and handpiece |
| Energy Source | Diode laser | Diode laser |
| Wavelength | 808 nm | 808 nm |
| Spot size | 1.44cm2 | 1.2cm2 |
| Working Mode | Fast Mode | |
| Free Setting Mode | FHR Mode | |
| Standard Mode | ||
| Power | 144W | |
| 518.4W | 120W | |
| 432W | ||
| Power density | 100W/ cm2 | |
| 360W/ cm2 | 100W/ cm2 | |
| 360W/ cm2 | ||
| Fluency | ||
| (energy density) | ≤ 10 J/cm2 | |
| ≤ 120 J/cm2 | ≤ 10 J/cm2 | |
| ≤ 120 J/cm2 | ||
| Repetition Rate | ≤10 Hz | |
| ≤3 Hz | ≤10 Hz | |
| ≤3 Hz | ||
| Pulse Duration | ≤ 20 ms | |
| 5-200 ms | ≤ 20 ms | |
| 5-200 ms | ||
| Product Appearance | ||
| Design | Standard case | Desktop case |
| Electrical Safety | IEC 60601-1, | |
| IEC60601-1-2, | ||
| IEC 60601-2-22 and IEC 60825-1 | IEC 60601-1, | |
| IEC60601-1-2, | ||
| IEC 60601-2-22 and IEC 60825-1 | ||
| Biocompatibility | ISO 10993-5 and ISO 10993-10 | ISO 10993-5 and ISO 10993-10 |
Table 3-1 Comparison of Technology Characteristics between GP900A and Predicate Device
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| Item | Proposed Device(s) | Predicate Device |
|---|---|---|
| Product model | GP900Q | K123483 |
| Product Code | GEX | DLH-06 |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Intended Use | The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. | |
| The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. | ||
| The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. | ||
| The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. | ||
| The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. | The Diode Laser is intended for use in dermatologic and general surgical procedures. | |
| The Standard Mode is intended for hair removal, permanent hair reduction. | ||
| The FHR Mode is intended for hair removal, permanent hair reduction. | ||
| The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. | ||
| Configuration | Laser system and handpiece | Laser system and handpiece |
| Energy Source | Diode laser | Diode laser |
| Wavelength | 808 nm | 808 nm |
| Spot size | 1.44cm2 | 1.2cm2 |
| Working Mode | Fast Mode | |
| Free Setting Mode | FHR Mode | |
| Standard Mode | ||
| Power | 120W | |
| 432W | 120W | |
| 432W | ||
| Power density | 100W/ cm2 | |
| 360W/ cm2 | 100W/ cm2 | |
| 360W/ cm2 | ||
| Fluency | ||
| (energy density) | ≤ 10 J/cm2 | |
| ≤ 120 J/cm2 | ≤ 10 J/cm2 | |
| ≤ 120 J/cm2 | ||
| Repetition Rate | ≤10 Hz | |
| ≤3 Hz | ≤10 Hz | |
| ≤3 Hz | ||
| Pulse Duration | ≤ 20 ms | |
| 5-200 ms | ≤ 20 ms | |
| 5-200 ms | ||
| Product Appearance Design | Standard case | Desktop case |
| Electrical Safety | IEC 60601-1, | |
| IEC60601-1-2, | ||
| IEC 60601-2-22 and IEC 60825-1 | IEC 60601-1, | |
| IEC60601-1-2, | ||
| IEC 60601-2-22 and IEC 60825-1 | ||
| Biocompatibility | ISO 10993-5 and ISO 10993-10 | ISO 10993-5 and ISO 10993-10 |
| Performance | IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 | IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 |
Table 3-2 Comparison of Technology Characteristics between GP900Q and Predicate Device
The proposed device, Diode Laser Hair Removal System, is determined to be Substantially Equivalent (SE) to the predicate device, Diode Laser, in respect of safety and effectiveness.