(84 days)
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No
The summary describes a standard diode laser system for hair removal and general surgical procedures, with no mention of AI or ML capabilities in its operation or features.
No
The device is intended for dermatologic and general surgical procedures, specifically hair removal, which is typically considered a cosmetic or elective procedure rather than a therapeutic one addressing a disease or medical condition.
No
The device is described as a "surgical device" intended for "dermatologic and general surgical procedures" and "hair removal." There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines hardware components such as a semiconductor diode laser source, a handpiece, a footswitch, a power supply system, a cooling system, and different physical cases (standard case with wheels, desktop case). This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "surgical device" intended for "dermatologic and general surgical procedures" and "hair removal." It uses a laser to directly interact with the body's tissues.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to deliver laser energy to the skin.
Therefore, the Diode Laser System described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser 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.
Product codes
GEX
Device Description
The Diode Laser 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 (810 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 System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 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 mode.
The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 22, 2021
Shenzhen GSD Tech Co., Ltd. Huifang Yao Regulatory Engineer Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District Shenzhen, Guangdong 518106 China
Re: K213225
Trade/Device Name: Diode Laser System GP900A8, Diode Laser System GP900Q8 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: September 24, 2021 Received: September 29, 2021
Dear Huifang Yao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213225
Device Name Diode Laser System
Indications for Use (Describe)
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared: Sept. 24, 2021
This 510(k) Summary is being submitted in accordance with requirements of Title 21 CFR Section 807.92.
1. Submitter information
Shenzhen GSD Tech Co., Ltd Add.: Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District, Shenzhen, China 518106 Establishment Registration Number: 3006580954
Contact Person: Huifang Yao Position: Regulatory Engineer Phone: +86 15018526594 E-mail: zoe.yao190322@qq.com.com
2. Device information
Trade name: Diode Laser System Model number: GP900A8, GP900Q8 Regulation number: 21CFR 878.4810 Regulation name: Powered Laser Surgical Instrument Regulatory class: II Panel: General & Plastic Surgery Product code: GEX
3. Predicate device information
510(k) Number: K142186 Device Name: Diode Laser Hair Removal System Manufacturer: Shenzhen GSD Tech Co., Ltd.
4. Device description
The Diode Laser 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 (810 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 System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 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
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mode.
The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.
5. Intended use
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair reduction in hair regrowth. The Diode Laser 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.
| Description | Subject device | Predicate device | Rem |
|---|---|---|---|
| ark | |||
| Company | Shenzhen GSD Tech Co., Ltd. | Shenzhen GSD Tech Co., Ltd. | / |
| Device name and | |||
| model | Diode Laser System | ||
| Models: GP900A8, GP900Q8 | Diode Laser Hair Removal System | ||
| Models: GP900A, GP900Q | / | ||
| 510 (k) number | / | K142186 | / |
| Classification name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | SE |
| Product code | GEX | GEX | SE |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Indications for use/ | |||
| Intended use | The Diode Laser System is intended | ||
| for use in dermatologic and general | |||
| surgical procedures. The Fast Mode is | |||
| intended for hair removal of unwanted | |||
| hair, and permanent hair reduction in | |||
| hair regrowth. The Free Mode is | |||
| intended for hair removal of unwanted | |||
| hair, and permanent hair reduction in | |||
| hair regrowth. The Diode Laser | |||
| 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 | The Diode Laser System is intended | ||
| for use in dermatologic and general | |||
| surgical procedures. The Fast Mode | |||
| is intended for hair removal of | |||
| unwanted hair, and permanent hair | |||
| reduction in hair regrowth. The Free | |||
| Setting Mode is intended for hair | |||
| removal of unwanted hair, and | |||
| permanent hair reduction in hair | |||
| regrowth. The Diode Laser 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, | SE | ||
| regrowing when measured at 6, 9 and | |||
| 12 months after the completion of a | |||
| treatment regime. | stable reduction in the number of | ||
| hair regrowing when measured at 6, | |||
| 9 and 12 months after the completion | |||
| of a treatment regime. | |||
| Configuration | Main unit | ||
| Handpiece | |||
| Foot control | Main unit | ||
| Handpiece | |||
| Foot control | SE | ||
| Energy source | Diode laser | Diode laser | SE |
| Laser classification | Class IV | Class IV | SE |
| Wavelength | $810nm\pm5nm$ | 808nm | SE |
| Spot size | 2cm² (10mm*20mm) | 1.44cm²(12mm*12mm) | Note |
| 1 | |||
| Working mode | Fast mode & Free mode | Fast mode & Free setting mode | SE |
| Fluency | |||
| (energy density) | 5~50J/cm² | 1~120J/cm² | Note |
| 2 | |||
| Repetition rate | 1~10Hz | 1~10Hz | SE |
| Pulse duration | 13-200ms | 5-200ms | Similar |
| Product appearance | |||
| design | GP900A8: Standard case | ||
| GP900Q8: Desktop case | GP900A: Standard case | ||
| GP900Q: Desktop case | SE | ||
| Dimension | GP900A8: 450mmx540mmx1080mm | ||
| GP900Q8: 650mmx460mmx370mm | GP900A: 445mmx554mmx1228mm | ||
| GP900Q: 505mmx363mmx344mm | Note | ||
| 3 | |||
| Weight | GP900A8: 54kg | ||
| GP900Q8: 30kg | GP900A: 52kg | ||
| GP900Q: 22kg | Note | ||
| 4 | |||
| Electrical Safety | Comply with IEC 60601-1, IEC | ||
| 60601-2-22 and IEC 60825-1 | Comply with IEC 60601-1, IEC | ||
| 60601-2-22 and IEC 60825-1 | SE | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Biocompatibility | Comply with ISO 10993-5 and ISO | ||
| 10993-10 | Comply with ISO 10993-5 and ISO | ||
| 10993-10 | SE |
6. Technological characteristics and substantial equivalence:
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Note 1: Spot size only affects the area of treatment, not the therapeutic effect. Therefore, this difference will not affect the safety and effectiveness.
Note 2: The fluence of the subject device is within the range of the predicate devices. And the subject device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test and IEC60825-1 test, the safety and performance of the product can be ensured. So the subject device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.
Note 3/4: The subject device is different in dimension and weight from the
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predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the safety and effectiveness.
7. Nonclinical tests submitted
● Safety test
IEC 60601-1: 2005/A1: 2012
Medical electrical equipment Part1: General requirements for basic safety and essential performance
● EMC test
IEC 60601-1-2: 2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances-Requirements and tests
● Reliability test
IEC 60601-2-22: 2019
Medical Electrical Equipment - Part 2-22: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1: 2014
Safety of laser products - Part 1: Equipment classification and requirements.
● Biocompatibility test
ISO 10993-5: 2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2010
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests.
8. Conclusion
The subject devices have the same intended use and same technological characteristics as the predicate device. Moreover the differences between the subject and predicate don't raise new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the Predicate Device.