DIODE LASER FOR HIAR REMOVAL

K131838 · Beijing Honkon Technologies Co., Ltd. · GEX · Apr 24, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131838
• Device Name: DIODE LASER FOR HIAR REMOVAL
• Applicant: Beijing Honkon Technologies Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 for hair removal; utilizes selective photothermolysis to heat melanin and hair follicles while sparing surrounding tissue. Device components include semiconductor solid-state lasers, switching power supply, treatment handle, and contact cooling system. Operated by clinicians in professional settings. Input parameters include wavelength (808nm), pulse duration (5-300ms), frequency (1-10Hz), and fluence (<120 J/cm²). Output is laser energy delivered via sapphire-tipped handle to axilla, facial, and neck regions. Clinical benefit is long-term, stable reduction in hair regrowth.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with electrical and radiation safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, 21 CFR 1040) was used to establish substantial equivalence.

Technological Characteristics

Diode laser system; 808nm wavelength; sapphire contact cooling; output power 30W; fluence <120 J/cm²; pulse duration 5-300ms; frequency 1-10Hz. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), and IEC 60825-1. Standalone device.

Indications for Use

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

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

• K112031

Submission Summary (Full Text)

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# K131838

| Image: HONKON logo and Beijing company name | | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | 510(k) Premarket Notification Submission | |
| | 510(k) Summary | APR 2 4 2014 |
| Date:<br>Submitter: | In accordance with 21 CFR 807.92 the following summary of information is provided:<br>18 June, 2013<br>Beijing Honkon Technologies Co., Ltd.<br>Address: No.3 Building, No.11 Yard, Kangding Street, BDA,<br>100176, Beijing, P.R.China | |
| Primary Contact Person: | Mike Gu<br>Regulatory Affairs Manager<br>OSMUNDA Medical Device Consulting Co., Ltd.<br>Tel: [phone]<br>Fax: [phone] | |
| Secondary Contact Person: | Li Zhao<br>Management Representative<br>Beijing Honkon Technologies Co., Ltd.<br>Tel: [phone]<br>Fax: [phone] | |
| Trade Name:<br>Common/Usual Name:<br>Classification Names: | Diode Laser for Hair Removal<br>Diode Laser<br>Powered Laser Surgical Instrument | |
| Regulation number | 878.4810 | |
| Product Code: | GEX | |
| Predicate Device(s):<br>Device Description: | K112031<br>The diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is | |

described in the table below:

| Model | Dimension (width* length* high) mm | |
|-------|------------------------------------|---------------|
| | Before package | After package |
| 808CL | 815*530*1420 | 895*590*1510 |
| 808CM | 790*540*1300 | 870*600*2200 |
| 808CH | 775*510*1395- | 855*570*1485 |
| 808EH | 810*530*1060 | 890*570*1960 |
| 808BL | 810*550*1300 | 890*610*1390 |
| 808BM | 820*590*1210 | 900*650*1300 |
| 808BH | 820*590*1280 | 900*650*1370 |
| 808DH | 780*620*1110 | 860*680*1200 |

Confidential and Privileged. This document confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved

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**HONKON**
气安星激光技术有限公司

510(k) Premarket Notification Submission

Proposed device

Technologies Co., Ltd

808CH, 808EH, 808BL,

808FH, 808HGG

Honkon

808CM,

808BH,

-

Modified

Treatment

Module

Beijing

808CL,

808BM,

| 808FH | 785*620*1180 | arrange a datt - a sua man a manufacturer and any final possible of the province<br>865*680*1270 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------|
| 808HGG<br>The first from the may in the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the coun | 780*630*1290 | 860*690*1380 |

| Intended Use: | The Honkon's diode laser for hair removal is intended for hair<br>removal, permanent hair reduction on all skin types (Fitzpatrick<br>skin type I-VI).<br><br>Permanent hair reduction is defined as the long-term, stable<br>reduction in the number of hairs regrowing when measured at 6,<br>9 and 12 months after the completion of a treatment regime |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The principle of laser hair removal is selective photothermolysis, the<br>matching of a specific wavelength of light and pulse duration to obtain<br>optimal effect on a targeted tissue with minimal effect on surrounding<br>tissue. Laser can cause localized damage by selectively heating melanin<br>and follicle while not heating the rest of the skin. |

| Determination of | Specification | Predicate Device |
|--------------------------|---------------|-------------------|
| Substantial Equivalence: | | |
| | K number | K112031 |
| | Manufacturer | Alma Lasers, Inc. |

Model

.

Confidential and Privileged. This document confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologics Co., Ltd. All rights reserved

Alma

Diode

with

Mode for

Lasers

HR

Laser

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510(k) Premarket Notification Submission

| Intended Use | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The HR Mode is<br>intended for hair<br>removal, permanent hair<br>reduction. (Fitzpatrick<br>skin types I-VI), including<br>tanned skin. | The diode laser for<br>hair removal is<br>intended for hair<br>removal, permanent<br>hair reduction on all<br>skin types (Fitzpatrick<br>skin type I-VI).<br>Permanent hair<br>reduction is defined<br>as the long-term,<br>stable reduction in<br>the number of hairs<br>regrowing when<br>measured at 6, 9 and<br>12 months after the<br>completion of a<br>treatment regime |
| Wavelength<br>(nm) | 810 | 808 |
| Output power<br>(W) | 30 | 30 |
| Fluence (Energy<br>Density) | <120 J/cm² | <120 J/cm² |
| Pulse Duration | 5-200ms | 5-300 ms |
| Frequency | Up to 10Hz | 1-10Hz |
| Spot Size | 12cm² | 12mm² |
| Material | Sapphire | Sapphire |
| Cooling | Contact cooling | Contact cooling |
| Anatomical Sites | Axilla, Facial, Neck | Axilla, Facial, Neck |
| Electrical Safety | Comply with IEC 60601-<br>1 and IEC 60601-1-2 | Comply with IEC<br>60601-1 and IEC<br>60601-1-2 |
| Radiation Safety | Comply with IEC 60601-<br>2-22, IEC 60825-1 and 21<br>CFR 1040<br>PERFORMANCE<br>STANDARDS FOR LIGHT-<br>EMITTING PRODUCTS | Comply with IEC<br>60601-2-22, IEC<br>60825-1 and 21 CFR<br>1040 PERFORMANCE<br>STANDARDS FOR<br>LIGHT-EMITTING<br>PRODUCTS |

Confidential and Privileged. This document confidential and priviteged trade secrets and other information of Beijing Connection and Printegor. The Locallion Called on thers not printers and soles and Ministman of Colling Honkon i'cchnologies Co., Ltd. All
rights reserved

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Image /page/3/Picture/0 description: The image shows the word "HONKON" in bold, black letters. Below the word "HONKON" is a line of Chinese characters. The characters appear to be a company name.

#### 510(k) Premarket Notification Submission

Conclusion:

The Diode Laser for Hair Removaland its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Therefore, Beijing Honkonstatesthat the non-clinical tests determined that the Diode Laser for Hair Removal to be as safe, as effective and performance is substantially equivalent to the predicate device(s).

Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2014

Osmunda Medical Device Consulting Company, Ltd. Mr. Mike Gu Regulatory Affairs Manager 7th floor, Jingui Business Building, 982 Congyun Road Baiyun District, 510420, Guangzhou, China

Re: K131838

Trade/Device Name: Diode Laser for Hair Removal Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 25, 2014 Received: March 27, 2015

Dear Mr. Gu:

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. Iisting 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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Page 2 - Mr. Mike Gu

device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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., M.B.A., F.A.C.S.

- Acting Director
- Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K131838

Device Name Diode Laser for Hair Removal

#### Indications for Use (Describe)

The diode laser for hair removal, permanent hair reduction on all skin types (Fitzpatick skin type I-V).

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Neil R Ogden 2014.04.23 15:34:14

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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