Q-SWITCHED ND:YAG LASER

K131857 · Beijing Honkon Technologies Co., Ltd. · GEX · Jan 16, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131857
• Device Name: Q-SWITCHED ND:YAG LASER
• Applicant: Beijing Honkon Technologies Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) Ota's nevus 532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos

Device Story

Q-Switched Nd:YAG laser system (models YILIYA-1064QCH, YILIYA-1064QCL, Aeslight-1064QEH) for dermatological procedures. Device utilizes Nd:YAG laser medium to generate 1064 nm and 532 nm wavelengths; energy delivered via articulated arm. System includes control unit, power supply, cooling system, and foot switch. Operated by clinicians in clinical settings. Output energy and pulse width parameters adjusted for specific tattoo ink colors or pigmented lesions. Aiming provided by red beam or viewfinder. Laser energy targets chromophores in skin to facilitate tattoo removal and lesion treatment. Bench testing confirms performance specifications.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards verified.

Technological Characteristics

Nd:YAG laser medium; 1064 nm and 532 nm wavelengths; Class 4 laser; 6-10 ns pulse width; 1-10 Hz repetition rate; 800 mJ max output energy; 2-7 mm spot size. System includes articulated arm, cooling system, and control unit. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for tattoo removal (dark ink, black/blue with 1064 nm; light ink, red, sky blue, green with 532 nm) and treatment of pigmented lesions (Ota's nevus, solar lentiginos, senile lentiginos) in patients requiring laser surgical intervention.

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

• RevLite™ Q-Switched Nd: YAG Laser System (K063834)

Submission Summary (Full Text)

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Exhibit #4 510(k) Summary

Project #:M0272013Bd

### 1 6 2014 JAN

## Exhibit #4 510(k) Summary

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

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- Date of Prepared: 01/11/2014 1.
- 2. Sponsor

Beijing Honkon Technologies Co., Ltd. No.3 Building, No.11 Yard, Kangding Street, BDA, 100176,Beijing, P.R.China

Establishment Registration Number: Not yet registered

Contact Person: Li Zhao Position: Management Representative Tel: [phone] ext. 508 Fax: [phone] ext. 610 Email: [e-mail]

- Submission Correspondent 3.
Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- नं Proposed Device Identification
Proposed Device Name: Q-Switched ND: YAG Laser Device Common Name: Laser Device Proposed Device Model: YILIYA- 1064QCH, YILIYA- 1064QCL, Aeslight- 1064QEH

Classification: Classification Name: powered laser surgical instrument Classification: 11; Product Code: GEX: Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Intended Use Statement:

1064 nm wavelength:

Tattoo Removal (Dark Ink, Black & Blue )

Ota's nevus

532 nm wavelength:

Tattoo Removal (Light Ink, Red, Sky Blue and Green)

Treatment of Pigmented Lesions

Solar Lentiginos

Senile Lentiginos

5. Predicate Device Identification

> 510(k) Number: K063834 Product Name: RevLite™ Q-Switched Nd: YAG Laser System Manufacturer: Hoya ConBio, Inc.

#### Device Description 6.

.

The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the

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waveform as 1064 nm and 532 nm.

The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.

- 7. Non-Clinical Test Conclusion
Bench 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, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for b) Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
- IEC 60601-2-22 (1995) Medical Electrical Equipment Part 2: Particular requirements for c) the safety of diagnostic and therapeutic.
- IEC 60825-: 2007 Safety of laser products Part 1: Equipment classification and requirements d)
- 8. Technological Characteristics Comparison

The proposed device has the same technological characteristics with the predicate device, such as Laser Medium, wavelength, control method and intended use.

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

| ITEM | Proposed Device | | | Predicate Device k063834 | | |
|---------------------------|-----------------|--------------------|-----------|-------------------------------------------------------|--|--|
| Product Name | YILIYA- | YILIYA- | Aeslight- | RevLite™ Q-Switched Nd: YAG | | |
| | 1064QCH | 1064QCL | 1064QEH | Laser System | | |
| Laser Medium | Nd: YAG | | | Nd: YAG | | |
| wavelength | 1064 nm | | | 1064 nm | | |
| | | 532 nm | | 532 nm | | |
| Output energy | 800 mJ at max. | | | 1600 mJ @ 1064 nm | | |
| | | | | 500 mJ @ 532 nm | | |
| Energy<br>Max.<br>Density | | 25.47J/cm2 at max. | | 22.64J/cm2 | | |
| Spot Size | | 2-7 mm | | 3. 4. 6& 8 mm (a) 1064 nm<br>2, 3, 4 & 6 mm (a,532 nm | | |
| Pulse Width | 6-10 ns | | | 5-20 ns | | |

| Table III-1 | | Comparison Table | |
|-------------|--|------------------|--|
| | | | |

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| Repetition Rate | 1-10 Hz | 1, 2, 5, 10 Hz |
|----------------------|---------------------------------------------------------------------------------------------------------------------|-----------------|
| Power<br>calibration | The device is calibrated by laser<br>energy/power meter no less than 1<br>time each year | --- |
| Laser Class | Class 4 | Class 4 |
| Aiming Beam | A focusing device (viewfinder) fitted<br>on the end instead of aiming beam<br>And<br>A red aiming beam for 1064 QEH | Red Aiming Beam |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Beijing Honkon Technologies Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

January 16, 2014

Re: K131857

· Trade/Device Name: YILIYA-1064QCH, YILIYA-1064QCL, and Aeslight-1064QEH 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: December 2, 2013 Received: December 6, 2013

Dear Ms. 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

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Page 2 - Ms. Diana Hong

CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

# Joshua C. Nipper -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) K131857

### Device Name YILIYA- 1064QCH, YILIYA- 1064QCL, Aeslight- 1064QEH

Indications for Use (Describe) 1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) .Ota's nevus

532 nm wavelength: Tattoo Removal (Light Ink. Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos

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)

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

FOR FOR FOR FOR FOR FOR FOR FOR USE ONLY - CHE CHARLES - CHEAR - CHEAR

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

Image /page/6/Picture/12 description: The image shows the name "Neil R Ogden -S" in bold black font on the top line. The second line shows the date and time "2014.01.14 16:15" also in bold black font. To the right of the name is a faded logo that is difficult to make out.

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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