(252 days)
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
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.
This document is an FDA 510(k) premarket notification for a medical device, specifically a "Diode Laser Hair Removal System." This type of document is focused on demonstrating substantial equivalence to a previously approved device, not on proving new clinical efficacy through de novo studies with specific acceptance criteria as you might see for novel AI/ML devices. Therefore, much of the information you've requested regarding acceptance criteria, sample sizes for test/training sets, experts for ground truth, MRMC studies, and effect sizes of human readers with AI assistance, is not applicable to this type of submission.
The "acceptance criteria" here are essentially compliance with recognized safety and performance standards for similar laser devices and demonstrating that the proposed device is functionally equivalent to an existing predicate device.
Here's an attempt to answer your questions based on the provided document, indicating what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, hair reduction percentage). Instead, "acceptance criteria" are implied by compliance with established safety and performance standards and direct comparison of technical specifications to a predicate device.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance (as compared to predicate) |
|---|---|
| Electrical Safety Standards Compliance: - IEC 60601-1: General requirements for safety - IEC 60601-1-2: Electromagnetic compatibility - IEC 60601-2-22: Basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating electrical safety equivalent to the predicate device. |
| Laser Safety Standards Compliance: - IEC 60825-1: Equipment classification and requirements | The proposed device (GP900A/GP900Q) complies with this standard, demonstrating laser safety equivalent to the predicate device. |
| Biocompatibility Standards Compliance: - ISO 10993-5: In Vitro Cytotoxicity - ISO 10993-10: Irritation and skin sensitization | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating biocompatibility equivalent to the predicate device. |
| Technical Specifications Equivalence to Predicate: - Energy Source: Diode laser - Wavelength: 808 nm - Fluency (energy density): ≤ 10 J/cm2 (Fast Mode), ≤ 120 J/cm2 (Free Setting Mode) - Repetition Rate: ≤10 Hz (Fast Mode), ≤3 Hz (Free Setting Mode) - Pulse Duration: ≤ 20 ms (Fast Mode), 5-200 ms (Free Setting Mode) | The proposed devices (GP900A/GP900Q) match the predicate device in these key technical specifications, indicating equivalent performance characteristics for hair removal. (Minor differences in spot size and max power were noted but deemed not to affect substantial equivalence). |
| Intended Use Equivalence: - Hair removal of unwanted hair - Permanent reduction in hair regrowth - Use on all skin types (Fitzpatrick I-VI), including tanned skin | The proposed devices have identical intended uses as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket submission based on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. It does not present clinical study data with a "test set" in the context of AI/ML or efficacy trials. The "test results" mentioned in Section 7 refer to compliance testing with various international standards (e.g., IEC, ISO) for electrical safety, laser safety, and biocompatibility, not clinical performance data on human subjects.
Therefore, questions about sample size for a test set and data provenance are not applicable to this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
As there is no "test set" in a clinical sense with ground truth established by experts for performance evaluation, this question is not applicable. The "truth" in this submission relies on compliance with engineering and safety standards executed by certified testing laboratories and the established safety and efficacy profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there is no clinical test set requiring expert adjudication for ground truth, this question is not applicable.
5. 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
An MRMC comparative effectiveness study is designed for evaluating AI-assisted diagnostic or clinical decision support systems. This document is for a physical laser device, not an AI/ML software device. Therefore, an MRMC study was not done, and questions about effect size of human readers with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm. Since this is a physical laser device, not an algorithm, a "standalone algorithm performance" study was not done. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that this is a 510(k) for a physical laser hair removal device, the "ground truth" for its safety and performance is established through:
- Compliance with international safety and performance standards: (e.g., IEC 60601-1, IEC 60825-1, ISO 10993). This is typically shown by testing conducted by accredited labs.
- Demonstration of substantial equivalence to a legally marketed predicate device: This relies on the FDA having previously determined the predicate device to be safe and effective. The comparison table (Tables 3-1 and 3-2) in the document serves this purpose, showing that the proposed device's technical specifications and intended use closely match the predicate.
There is no "ground truth" derived from expert consensus, pathology, or outcomes data in this submission for clinical efficacy of the proposed device itself, as it is relying on the established record of the predicate and compliance with technical standards.
8. The sample size for the training set
This document describes a submission for a physical laser device, not an AI/ML system that requires a "training set." Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
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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
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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
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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)
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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
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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.
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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.
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- 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 isintended for use in dermatologic and generalsurgical procedures.The Fast Mode is intended for hair removalof unwanted hair, and permanent reduction inhair regrowth.The Free Setting Mode is intended for hairremoval of unwanted hair, and permanentreduction in hair regrowth.The Diode Laser Hair Removal System isintended for use on all skin types (Fitzpatrickskin types I-VI), including tanned skin.The permanent reduction in hair regrowth isdefined as long-term, stable reduction in thenumber of hair regrowing when measured at6, 9 and 12 months after the completion of atreatment regime. | The Diode Laser is intended for use indermatologic and general surgicalprocedures.The Standard Mode is intended for hairremoval, permanent hair reduction.The FHR Mode is intended for hairremoval, permanent hair reduction.The Diode Laser Hair Removal Systemis intended for use on all skin types(Fitzpatrick skin types I-VI), includingtanned 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 ModeFree Setting Mode | FHR ModeStandard Mode |
| Power | 144W518.4W | 120W432W |
| Power density | 100W/ cm2360W/ cm2 | 100W/ cm2360W/ 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 ms5-200 ms | ≤ 20 ms5-200 ms |
| Product AppearanceDesign | 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 ModeFree Setting Mode | FHR ModeStandard Mode |
| Power | 120W432W | 120W432W |
| Power density | 100W/ cm2360W/ cm2 | 100W/ cm2360W/ 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 ms5-200 ms | ≤ 20 ms5-200 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.
§ 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.