Diode Laser 808nm

K192516 · Beijing Superlaser Technology Co., Ltd. · GEX · Dec 10, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192516
• Device Name: Diode Laser 808nm
• Applicant: Beijing Superlaser Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diode Laser 808nm 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 808nm (Model SL-HR10) is a powered laser surgical instrument for hair removal; utilizes 808nm diode laser energy. System components: main unit, handpiece, foot control, water cooling system (refrigeration compressor/pump), power system, and user interface (touch screen). Operated by clinicians in professional settings. User sets parameters via interface; laser energy delivered through handpiece to target area. Cooling system manages thermal exchange during operation. Output is laser energy for hair follicle destruction. Benefits include permanent hair reduction. Device includes main circuit control for sequence management and fault monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety, electromagnetic compatibility, laser safety, and biocompatibility (cytotoxicity, irritation, sensitization).

Technological Characteristics

Diode laser (808nm); Class IV; 1.2 cm² spot size; 1-70 J/cm² fluence; 1-20 Hz frequency; 5-400ms pulse duration. Patient contact material: sapphire. Cooling: water-based with refrigeration compressor. Power: 110V/60Hz or 230V/50Hz. Standards: AAMI/ANSI/ES 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.

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 device (K180353)
• Diode laser System (K181019)

Submission Summary (Full Text)

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December 10, 2019

Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 China

Re: K192516

Trade/Device Name: Diode Laser 808nm, Model: SL-HR10 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 10, 2019 Received: September 13, 2019

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. 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

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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) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192516

Device Name Diode Laser 808nm, Model: SL-HR10

Indications for Use (Describe)

The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all 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> <span style="font-family: DejaVu Sans, sans-serif;"> ❌ </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-family: DejaVu Sans, sans-serif;"> ❍ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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:

- 1. Date of Preparation
09/10/2019

- Sponsor 2.
## Beijing Superlaser Technology Co., Ltd.

No.2 Zhongfu Street, Economic and Technological Industrial Zone, Xihongmen Town, Daxing District, Beijing, 100076, China

Contact Person: Shi Shuang Position: Registration Specialist Tel: [phone] to 806 Fax:[phone] Email: [e-mail]

#### 3. Submission Correspondent

Ray Wang General Manager

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 808nm Common Name: Powered Laser Surgical Instrument Model(s): SL-HR10

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Indication For Use:

The Diode Laser 808nm 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 Diode Laser 808nm 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.

The proposed device has six main function modules as following:

Water cooling system:

Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system.

### Power system:

Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system.

### User Interface system:

Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system.

### Handpiece system:

According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system.

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Main circuit power supply system:

The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system.

Main circuit control system:

It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.

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### 6. Identification of Predicate Device

510(k) Number: K181019 Product Name: Diode laser System Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd.

510(k) Number: K180353 Product Name: Diode laser hair removal device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., 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:

- > AAMI/ANSI/ES 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)
- 8. Clinical Test Conclusion

No clinical study is included in this submission.

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# 9. Substantially Equivalent (SE) Comparison

| Item | Proposed Device | Predicate Device<br>K180353 | Predicate Device<br>K181019 | Remark |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | GEX | SAME |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Intended Use | The Diode Laser 808nm 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 hair removal<br>device is intended for hair<br>removal, permanent hair<br>reduction on all skin types<br>(Fitzpatrick skin type I-VI),<br>including tanned skin.<br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of<br>hairs regrowing when measured<br>at 6, 9, and 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<br>on all skin types<br>(Fitzpatrick skin type<br>I-VI), including tanned<br>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. | SAME |
| Configuration | Main Unit | Main Unit | Main Unit | SAME |
| | Handpiece | Handpiece | Handpiece | SAME |
| | Foot Control | Foot Control | Foot Control | SAME |
| Principle of<br>Operation | Diode Laser | Diode Laser | Diode Laser | SAME |

# Table 7-1 General Comparison

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| Item | Proposed Device | Predicate Device<br>K180353 | Predicate Device<br>K181019 | Remark |
|-------------------------|----------------------------|-----------------------------|-----------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME |
| Laser<br>Classification | Class IV | Class IV | Class IV | SAME |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SAME |
| Spot Size | $1.2 cm^2$ | $1.44 cm^2$ | $1.2 cm^2$ | SAME |
| Fluence | $1-70J/ cm^2$ | $1-100J/ cm^2$ | $5-40J/ cm^2$ | Discussion |
| Frequency | 1-20 Hz | 1-20 Hz | 1-5 Hz | SAME |
| Pulse Duration | 5~400ms | 10~400ms | 30-200ms | SAME |
| Power Supply | 110V 60 Hz or 230V<br>50Hz | AC 110V/60Hz | 100-240V 50/60Hz | SAME |
| Dimension<br>(L*W*H) | 598mm x 440mm x<br>1093mm | 560mm x 380mm x 180mm | 450mm x 550mm x380mm | SIMILAR |
| Weight | 60Kg | 60Kg | 50 Kg | SAME |

Table 7-2 Performance Comparison

## Discussion

The proposed device is different in fluence from the predicate device, the difference is very slight, and only in the range, the max. fluence of proposed device is between the two predicate devices, which means the proposed device could accomplishment the same indication for use with two predicate device. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test , IEC60825-1 test and performance test(Energy density and Spot Size), the safety and performance of the product can be ensured.

So the proposed device is determined to be substantially equivalency with predicate device.

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| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|------------------------------------------------|--------------------------------------------|-----------------------------------------|-----------------------------------------|--------|
| | | K180353 | K181019 | |
| Patient Contact Materials and Biocompatibility | | | | |
| Patient Contact<br>Materials | Sapphire in handpiece | Sapphire in handpiece | Sapphire in handpiece | SAME |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME |
| Sensitization | No evidence of sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | SAME |
| EMC, Electrical and Laser Safety | | | | |
| Electrical<br>Safety | Comply with IEC 60601-1, IEC<br>60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC<br>60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SAME |

## Table 11-3 Safety Comparison

## 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.