Diode Laser System

K181019 · Guangzhou Huafei Tongda Technology Co., Ltd. · GEX · Jul 16, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181019
• Device Name: Diode Laser System
• Applicant: Guangzhou Huafei Tongda Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Diode Laser System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 regime.

Device Story

Diode Laser System (HF-108) is a surgical laser device for hair removal. Input: operator-selected laser energy parameters via control panel. Operation: microcontroller-based system manages constant current board to drive semiconductor laser; cooling system (condenser, cold plate, fans) maintains temperature/humidity; handpiece (sapphire tip) emits 808 nm laser energy. Output: laser energy delivered to patient skin. Used in clinical settings by trained operators. Healthcare provider uses LCD interface to set parameters and monitor system state (temperature, humidity, flow). Device provides permanent hair reduction by targeting hair follicles; cooling components protect skin and prevent device overheating.

Clinical Evidence

Bench testing only. No clinical data included in this submission.

Technological Characteristics

Diode laser (808 nm, Class IV). Handpiece materials: sapphire and aluminum alloy. Cooling: condenser, cold plate, water circulation, fans. Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10. Microcontroller-based control system for energy delivery and safety monitoring (over-current, over-voltage, over-temperature).

Indications for Use

Indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin.

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 Hair Removal System (K162659)
• SILKPRO Laser Hair Removal System (K142845)
• Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with Family of Soprano XL Multi-Application Platforms (K112031)
• Spirit Hair Removal Laser Family (K153718)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

July 16, 2018

Guangzhou Huafei Tongda Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, Xi Yue Hui, No.5, Yi He North Rd. Fang Shan District Beijing, 102401 Cn

Re: K181019

Trade/Device Name: 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: April 13, 2018 Received: April 17, 2018

Dear Ray Wang:

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, 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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

Also, please note the regulation entiled, "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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K181019

Device Name

Diode Laser System

#### Indications for Use (Describe)

The Diode Laser System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 regime.

Type of Use (Select one or both, as applicable)

| <span> <svg class="bi bi-check" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M13.854 3.646a.5.5 0 0 1 0 .708l-7 7a.5.5 0 0 1-.708 0l-3.5-3.5a.5.5 0 1 1 .708-.708L6.5 10.293l6.646-6.647a.5.5 0 0 1 .708 0z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K181019

- 1. Date of Preparation
06/19/2018

- Sponsor 2.
### Guangzhou Huafei Tongda Technology Co., Ltd.

4/F, Building B Industrial and Commercial Trading Park, Hainan Town, Huadi Dadao Nan Road, Fangcun, Liwan District, Guangzhou 510388, P.R. China

Contact Person: Liu Pengqi Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Diode Laser System Common Name: Powered Laser Surgical Instrument Model(s): HF-108

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:

The Diode Laser System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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 regime.

#### 5. Device Description

The proposed device, Diode Laser System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

#### Function module description

a. Control Panel

The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.

#### b. Main Control Module

The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.

c. Constant current board module

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The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.

#### d. Temperature and humidity control system

The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.

#### e. Handpiece module

Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

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#### 6. Identification of Predicate Device

510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd.

510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Co., Ltd.

510(k) Number: K112031 Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with Family of Soprano XL Multi-Application Platforms Manufacturer: Alma Lasers, Inc.

510(k) Number: K153718 Product Name: Spirit Hair Removal Laser Family. Spirit-918/cFactor -918/mFactor-918 Manufacturer: Active Optical Systems Ltd.

#### 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:

- A IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
- > IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For 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.
- > 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
- > ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
- > ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
- > Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
- 8. Clinical Test Conclusion

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No clinical study is included in this submission.

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# 9. Substantially Equivalent (SE) Comparison

| Item | Proposed Device | Predicate Device<br>K162659 | Predicate Device<br>K142845 | Predicate Device<br>K112031 | Predicate Device<br>K153718 | Remark |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | OHT | GEX | GEX | SE |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser System is<br>intended for hair removal,<br>permanent hair reduction on<br>all skin types (Fitzpatrick<br>skin type I-VI), including<br>tanned skin.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the<br>number of hairs regrowing<br>when measured at 6, 9, and<br>12 months after the<br>completion of a treatment<br>regime. | The Diode Laser System is<br>intended for hair removal,<br>permanent hair reduction on<br>all skin types (Fitzpatrick skin<br>type I-VI), including tanned<br>skin.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. | The SILKPRO is an<br>over-the-counter device intended<br>for adjunctive use with shaving<br>for hair removal sustained with<br>periodic treatments. SILKPRO is<br>also intended for permanent<br>reduction in hair regrowth<br>defined as a long-term, stable<br>reduction in hair counts<br>following a treatment regime.<br>permanent hair reduction is<br>defined as long term, stable<br>reduction in the number of hairs<br>regrowing when measured out to<br>6, 9, and 12 months after the<br>completion of the treatment<br>regimen | The Alma Lasers Family of Soprano<br>XL Multi-Application Platforms is<br>intended for use in dermatologic and<br>general surgical procedures.<br>The Alma Lasers Modified Diode<br>Laser Module (used with Alma<br>Lasers Family of Soprano XL<br>Multi-Application Platforms):<br>The HR modes is intended for hair<br>removal, permanent hair reduction.<br>The SHR Mode is intended for hair<br>removal, permanent hair reduction.<br>The LaserBlanche Mode is intended<br>for the treatment of benign vascular<br>and pigmented lesions.<br>The Alma Lasers Family of Soprano<br>XL Multi-Application Platforms is<br>intended for use on all skin types | The Spirit Hair Removal Laser<br>Family is generally intended for<br>dermatological use. The devices are<br>specifically indicated for hair<br>removal, permanent hair reduction<br>by using selective laser energy.<br>The Spirit Hair Removal Laser<br>Family is intended for use on all<br>skin types (Fitzpatrick skin types<br>I-VI), including tanned<br>skin.Permanent reduction in hair<br>regrowth is defined as long term,<br>stable reduction in the number of<br>hairs regrowing when measured out<br>to 6, 9, and 12 months after the<br>completion of the treatment regimen. | SE |

Table 7-1 General Comparison

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| | | | (Fitzpatrick skin types I-VI),<br>including tanned skin. | | | |
|---------------------------|--------------|--------------|----------------------------------------------------------|--------------|-------------|----|
| | Main Unit | Main Unit | / | Main Unit | / | SE |
| Configuration | Handpiece | Handpiece | Handpiece | Handpiece | Handpiece | SE |
| | Foot Control | Foot Control | / | Foot Control | / | SE |
| Principle of<br>Operation | Diode Laser | Diode Laser | Diode Laser | Diode Laser | Diode Laser | SE |

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| Item | Proposed Device | Predicate Device<br>K162659 | Predicate Device<br>K142845 | Predicate Device<br>K112031 | Predicate Device<br>K153718 | Remark |
|-------------------------|------------------------|-----------------------------|-----------------------------|-----------------------------------------------|-----------------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser | Diode Laser | SE |
| Laser<br>Classification | Class IV | Class IV | Class IV | Class IV | Class IV | SE |
| Laser<br>Wavelength | 808 nm | 808 nm | 810 nm | 810 nm | 810 nm | SE |
| Spot Size | 1.20cm² | 1.44 cm² | 9 x 9 mm (0.81 cm²) | 1.20cm² | 12 x 16 mm (1.92 cm²) (Model 918) | Discussion |
| Pulse<br>Duration | 30ms-200ms | 5-400ms | / | 5-200ms (HR Mode); ≤ 20ms (SHR Mode) | Up to 310 ms (Model 918) | Discussion |
| Fluence | 5-40 J/cm2 | 1-120J/ cm² | 5 - 25J/ cm2 | 1-120J/ cm² (HR Mode); ≤ 10 J/ cm² (SHR Mode) | 6-90 J/cm² (Model 918) | Discussion |
| Frequency | 1-5Hz | 0.5-15Hz | / | ≤ 3 Hz (HR Mode); ≤ 10 Hz (SHR Mode) | ≤ 10 Hz (Model 918) | Discussion |
| Power Supply | 100-240V~ 50/60Hz | AC 110V/60Hz | / | / | / | Discussion |
| Dimension | 510mm×600mm×<br>1000mm | 450mm×<br>550mm×380mm | / | / | / | Discussion |
| Weight | 50Kg | 52Kg | / | / | / | Discussion |

Table 7-2 Performance Comparison

Discussion

The proposed device has same indication for use with 4 predicate devices, such as spot size, fillerce, frequency range, pulse duration.

For these output parameters, the Fluence and Pulse the parameters which may decides that how much and how long time the energy will deliver to

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510(k) Summary

the patient's skin, it may effects the safety (too long action time) may burn patient's skin, and effectiveness (too low energy and or too short action time) may make the device could not achieve it's indication for use.

From the comparison above, the fluence of proposed device is 5-40 June, the finence of predicate device are 1-1200 cm², They are not exactly same, but the fluence of proposed or limited the fluence of predicate device. Because the maximum fluence of proposed are lover than some predicate device (120 J/cm²), it can be considered as the proposed device has acceptable safety; and the maximum fluence of proposed are higher than some rredicate device (25// on) , 10 J/ cm²) it can be croposed device has capable to achieve it's indication for use. The Pulse duration of proposed device is 30 ms -200 ms, which is similar with the pulse duration of predicate device, which is longer or same than some predicate device (200 ms, 400 ms), and less than some predicate device (20 ms), so same reason as fluence, the pulse device has acceptable safety and has capable to achieve it's indication for use.

As the justification above, the difference of pulse ranges does not affect the safety or effectiveness of proposed device for it's indications for use.

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# Table 7-3 Safety Comparison

| Item | Proposed Device | Predicate Device<br>K162659 | Predicate Device<br>K142845 | Predicate Device<br>K112031 | Predicate Device<br>K153718 | Remark |
|------------------------------------------------|---------------------------------------------|-----------------------------------------|-----------------------------|-----------------------------|-----------------------------|------------|
| Patient Contact Materials and Biocompatibility | | | | | | |
| Patient Contact<br>Materials | Sapphire and aluminum alloy in<br>handpiece | Sapphire in handpiece | | | | Discussion |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | | | | |
| Sensitization | No evidence of sensitization | No evidence of sensitization | | | | SE |
| Irritation | No evidence of irritation | No evidence of irritation | | | | |
| EMC, Electrical and Laser Safety | | | | | | |
| Electrical Safety | Comply with IEC 60601-1, IEC<br>60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | | | | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | | | | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC<br>60825 | Comply with IEC 60601-2-22, IEC 60825 | | | | SE |

# Discussion

The proposed device is different in Patient Contacte device. but both the predicate device and the proposed device has passed the 1SO 1099 series test, we believe these differences will not affectiveness and safety compared with the predicate is deternined to be substantially equivalency with predicate device.

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## 10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.