DIODE LASER HAIR REMOVAL SYSTEM

K142186 · Shenzhen Gsd Tech Co., Ltd. · GEX · Apr 17, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142186
• Device Name: DIODE LASER HAIR REMOVAL SYSTEM
• Applicant: Shenzhen Gsd Tech Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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 regiment

Device Story

Diode laser system (808 nm) for hair removal; utilizes semiconductor diode laser source; laser power delivered via handpiece; activated by footswitch. Two models: GP900A (floor-standing) and GP900Q (desktop). Includes power supply, central control, cooling, and laser delivery systems. Used in clinical settings by trained professionals. Output is infrared laser radiation; clinical effect is thermal destruction of hair follicles for permanent hair reduction. Healthcare providers use device to perform hair removal procedures; patient benefits from long-term reduction in unwanted hair.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser classification), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

808 nm semiconductor diode laser; 1.44 cm2 spot size; 120W-518.4W power; 100-360 W/cm2 power density; ≤10-120 J/cm2 fluence; ≤3-10 Hz repetition rate; 5-200 ms pulse duration. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10. Cooling system included.

Indications for Use

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

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

• Diode Laser (K123483)

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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:

- 1. Date of Submission: July 29, 2014
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong& Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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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.

- 7. 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:

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 is<br>intended for use in dermatologic and general<br>surgical procedures.<br>The Fast Mode is intended for hair removal<br>of unwanted hair, and permanent reduction in<br>hair regrowth.<br>The Free Setting Mode is intended for hair<br>removal of unwanted hair, and permanent<br>reduction in hair regrowth.<br>The Diode Laser Hair Removal System is<br>intended for use on all skin types (Fitzpatrick<br>skin types I-VI), including tanned skin.<br>The permanent reduction in hair regrowth is<br>defined as long-term, stable reduction in the<br>number of hair regrowing when measured at<br>6, 9 and 12 months after the completion of a<br>treatment regime. | The Diode Laser is intended for use in<br>dermatologic and general surgical<br>procedures.<br>The Standard Mode is intended for hair<br>removal, permanent hair reduction.<br>The FHR Mode is intended for hair<br>removal, permanent hair reduction.<br>The Diode Laser Hair Removal System<br>is intended for use on all skin types<br>(Fitzpatrick skin types I-VI), including<br>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<br>Free Setting Mode | FHR Mode<br>Standard Mode |
| Power | 144W<br>518.4W | 120W<br>432W |
| Power density | 100W/ cm2<br>360W/ cm2 | 100W/ cm2<br>360W/ cm2 |
| Fluency<br>(energy density) | ≤ 10 J/cm2<br>≤ 120 J/cm2 | ≤ 10 J/cm2<br>≤ 120 J/cm2 |
| Repetition Rate | ≤10 Hz<br>≤3 Hz | ≤10 Hz<br>≤3 Hz |
| Pulse Duration | ≤ 20 ms<br>5-200 ms | ≤ 20 ms<br>5-200 ms |
| Product Appearance<br>Design | Standard case | Desktop case |
| Electrical Safety | IEC 60601-1,<br>IEC60601-1-2,<br>IEC 60601-2-22 and IEC 60825-1 | IEC 60601-1,<br>IEC60601-1-2,<br>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.<br>The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth.<br>The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth.<br>The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.<br>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.<br>The Standard Mode is intended for hair removal, permanent hair reduction.<br>The FHR Mode is intended for hair removal, permanent hair reduction.<br>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<br>Free Setting Mode | FHR Mode<br>Standard Mode |
| Power | 120W<br>432W | 120W<br>432W |
| Power density | 100W/ cm2<br>360W/ cm2 | 100W/ cm2<br>360W/ cm2 |
| Fluency<br>(energy density) | ≤ 10 J/cm2<br>≤ 120 J/cm2 | ≤ 10 J/cm2<br>≤ 120 J/cm2 |
| Repetition Rate | ≤10 Hz<br>≤3 Hz | ≤10 Hz<br>≤3 Hz |
| Pulse Duration | ≤ 20 ms<br>5-200 ms | ≤ 20 ms<br>5-200 ms |
| Product Appearance Design | Standard case | Desktop case |
| Electrical Safety | IEC 60601-1,<br>IEC60601-1-2,<br>IEC 60601-2-22 and IEC 60825-1 | IEC 60601-1,<br>IEC60601-1-2,<br>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.