MEDICAL DIODE LASER SYSTEMS

K160549 · Wuhan Gigaa Optronics Technology Co., Ltd. · GEX · Apr 7, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K160549
• Device Name: MEDICAL DIODE LASER SYSTEMS
• Applicant: Wuhan Gigaa Optronics Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "VELAS II -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Device Story

Medical diode laser system (VELAS II-15D) uses GaAlAs semiconductor diode bar to generate 1470nm laser energy. Device includes main unit, color LCD touch screen, footswitch, and power detector. User sets parameters via interface; system requires protective eyewear (800-1700nm) before activation. Laser energy is delivered via external disposable sterile fiber (SMA905 connector, 600μm core) to target tissue. Used by clinicians for endovenous laser treatment of saphenous vein reflux. System features beam shaping for efficient fiber coupling. Operation modes include CW, single pulse, and repeat pulse. Provides thermal ablation of vein, resulting in vein closure and symptom relief for patients with varicose veins.

Clinical Evidence

Bench testing only. Compliance with IEC60601-1, IEC60601-1-2, IEC60601-2-22, and IEC60825-1 standards. Software verification performed per FDA guidance.

Technological Characteristics

GaAlAs diode laser; 1470nm wavelength; 1-15W output power; CW/pulse modes. Dimensions: 400x385x200mm; Weight: 12.9kg. Interface: Color LCD touch screen. Power: 100-240VAC. Standards: IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1. Fiber delivery: SMA905 connector, 600μm core, NA ≥0.22. IPX1 main unit, IPX8 footswitch.

Indications for Use

Indicated for treatment of reflux of saphenous veins associated with varicose veins and varicosities.

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

• 15W Ceralas D 1470nm Diode Laser, D1470 (K082225)

Reference Devices

• Disposable sterile fiber (K124003)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that resemble a stylized wing or flame.

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

April 7, 2017

Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing Regulation Control Manager 5, 6/F, Unit A, B, Building B8, Hi-tech Medical Device Industrial Park, #818 Gaoxin Avenue East Lake Development Zone, Wuhan, 430206 CN

Re: K160549

Trade/Device Name: Medical Diode Laser Systems 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: February 27, 2017 Received: March 6, 2017

Dear Nie Xinxing:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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,

# Jennifer R. Stevenson -S

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

## Indications for Use

510(k) Number (if known) K160549

Device Name Medical Diode Laser Systems

Indications for Use (Describe)

The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Section 5 - 510(k) Summary

Date of Summary Preparation: February 22, 2016 Date of Summary Revision: February 27, 2017

### 1. Submitter's Identifications

Submitter's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206,China Contact Person: Nie Xin xing Contact Email Address: fdagigaalaser(@sohu.com Telephone: [phone]-8045 Fax: [phone]

## 2. Correspondent's Identifications

Correspondent's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206, China Contact Person: Nie Xinxing Contact Email Address: fdagigaalaser(@sohu.com Telephone: [phone]-8045 Fax: [phone]

## 3. Name of the Device

Device Classification Name: POWERED LASER SURGICAL INSTRUMENT Product Name: POWERED LASER SURGICAL INSTRUMENT Trade Name: Medical diode laser systems Model: VELAS II -15D Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II

## 4. The Predicate Devices

K082225 15W Ceralas D 1470nm Diode Laser, D1470

#### 5. Device Description

Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser

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Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up.

After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.

## 6. Intended Use of Device

Intended Use of Medical Diode Laser Systems "VELAS II -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

## 7. Summary of Substantial Equivalence

| | Proposed Device | Predicate device | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | ------- | K082225 | ------- |
| Product Code | GEX | GEX | Same |
| Proprietary<br>Name | Medical Diode Laser<br>Systems | 15W Ceralas D 1470nm<br>Diode Laser | ------- |
| Model | VELAS II -15D | D1470 | ------- |
| Manufacturer | Wuhan Gigaa Optronics<br>Technology Co., Ltd | Biolitec, Inc. | ------- |
| Indications for<br>use | The "VELAS II -15D" is<br>indicated for use in the<br>treatment of reflux of<br>the saphenous veins<br>associated with varicose<br>veins and varicosities. | The device is indicated<br>for the treatment of<br>reflux of the saphenous<br>veins associated with<br>varicose veins and<br>varicosities. | Same |
| Laser Type | diode laser | diode laser | Same |
| Components | Laser system, Color<br>touch screen, Foot<br>switch, Power detector | Laser system, Color<br>touch screen, Fiber and<br>the handpiece, Foot<br>switch, Power detector | Similar.<br>Handpiece in D1470 as<br>the laser transmission<br>system used with<br>optical fiber together.<br>VELAS II -15D does<br>not equip with fiber and<br>handpiece, but<br>recommending a |
| | | | |
| | | | disposable sterile fiber<br>(K124003,<br>MED-Fibers, Inc.)<br>registered in U.S.A, not<br>affect the safety and<br>effectiveness. |
| Wavelength | $1470nm\pm10nm$ | $1470nm\pm30nm$ | Similar.<br>Center wavelength is<br>consistent, and<br>wavelength accuracy of<br>VELAS II -15D is better<br>than that of the<br>predicate device. |
| Output power | 1-15W | 1-15W | Same |
| Operation mode | CW, single pulse, repeat pulse | CW, single pulse, repeat pulse | Same |
| Pulse width | 10ms-2.5s | 0.01s -60s | Similar.<br>Pulse width range of the<br>device is contained in<br>that of the predicate<br>device, and it has been<br>designed to meet the<br>intended use<br>requirement claimed. |
| Pulse repetition rate | 0.2Hz-50Hz | 0.01Hz-50Hz | Similar.<br>Pulse repetition rate is<br>slight similar, not affect<br>safety and effectiveness. |
| Application /<br>Light delivery<br>system | It is recommended to<br>use the disposable<br>sterile fiber (K124003,<br>MED-Fibers, Inc.)<br>registered in U.S.A.<br>The parameters must<br>meet the following<br>requirements:<br>• bare fiber, long as 3m<br>• Fiber core diameter:<br>600μm<br>• NA ≥0.22<br>• With SMA905<br>connector<br>• Single used | Fiber diameter ≥ 360μm | Similar.<br>VELAS II -15D is<br>described more detailed.<br>Fiber core diameter<br>range of VELAS II -15D<br>is contained in that of<br>the predicate device,<br>and it has been designed<br>to meet the intended use<br>requirement claimed. |
| Aiming Beam | Diode<br>laser of<br>635/532nm, power max.<br>< 5mW, adjustable<br>brightness. | 532nm and 635nm,<br>green 1mW, red 4 mW,<br>user controlled intensity | Similar.<br>Aiming beam power<br>range of VELAS II -15D<br>contains that of the<br>predicate device, and it<br>has been designed to<br>meet the intended use<br>requirement claimed. |
| Laser Class | 4 | 4 | Same |
| Operation<br>interface | Color LCD touch screen | Color LCD touch screen | Same |
| Power Supply | 100-240VAC, 50/60Hz,<br>350VA | 220-240 VAC, 50/60Hz,<br>450VA | Similar.<br>Only rated power is<br>different, not affect<br>safety and effectiveness. |
| Safety<br>classification | Class I Type B | Class I Type B | Same |
| Dimensions | 400(W)*385(L)*200(H)<br>mm | 370(W)*90(L)*280(H)<br>mm | Similar.<br>VELAS II -15D<br>is<br>bigger<br>than<br>the<br>predicate device. |
| Weight | 12.9kg | 8.5kg | Similar.<br>VELAS II -15D<br>is<br>heavier<br>than<br>the<br>predicate device. |
| Waterproof<br>level | IPX1 | IPX1 | Same |
| Footswitch<br>Waterproof<br>level | IPX8 | IPX8 | Same |
| Standard | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-22<br>IEC60825-1 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-22<br>IEC60825-1 | Same |
| Non- sterile | Fiber is sterilized<br>by<br>EO. | Fiber is sterilized<br>by<br>EO. | Same |
| Microprocessor<br>Control | Yes | Yes | Same |

#### Table 1

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## Wuhan Gigaa Optronics Technology Co., Ltd

## 8. Substantial Equivalence:

The proposed device of VELAS II -15D has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device.

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## Wuhan Gigaa Optronics Technology Co., Ltd

The differences only exist in such contents: component of handpiece that do not influence use even if without it, wave rang of wavelength, output power, pulse width, pulse repetition rate and aiming beam that all can be controlled in range of application. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.

## 9. Non-Clinical Tests Performed:

The following testing was performed on the "VELAS II-15D" Medical Diode Laser Systems in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005+A1:2012+National differences of US ANSI/AAMI Medical electrical equipment-Part 1: General requirements for basic safety and essential performance Incorporates Amendment 1:2012; Incorporates National differences of US ANSI/AAMI

ES60601-1:2005+C1:2009+A2:2010+A1:2012 Medical equipment-Part 1: General requirements for basic safety and essential performance Consolidated reprint C1:2009; Incorporates Amendment 2:2010; Incorporates Amendment 1:2012

IEC60601-2-22:2007+A1:2012 Medical electrical equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Incorporates Amendment 1:2012

IEC60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC60825-1:2007 Safety of laser products-Part 1: Equipment classification and requirements In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

## 10. Conclusion:

The proposed devices of VELAS II-15D is determined to be Substantially Equivalent (SE) to the predicate device, 15W Ceralas D 1470nm Diode Laser, D1470 in respect of safety and effectiveness.

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