FIBERLASE C02 LASER WAVEGUIDE

K100384 · Lumenis, Ltd. · GEX · Apr 12, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100384
• Device Name: FIBERLASE C02 LASER WAVEGUIDE
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2 Laser WaveGuide Delivery System is intended for use in open and laparoscopic surgical procedures for ablation, vaporization, excision, and coagulation of soft tissue.

Device Story

FiberLase CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube for CO2 laser energy delivery. Input: 10.6 µm CO2 laser beam and 0.6328 µm HeNe aiming beam. Operation: laser energy enters via 905 SMA connector; travels through tube via multiple internal reflections; delivered to tissue at distal end. Used in OR/clinic by surgeons for soft tissue procedures. Includes handpieces for handling and beam deflection; cleaving/cutting tools; optional gas purge system (air flow 2 L/min, 4.5 psi) to maintain channel clarity. Output: focused laser energy for tissue interaction. Benefits: enables precise, minimally invasive surgical access for ablation/coagulation.

Clinical Evidence

Bench testing only. Testing evaluated percent transmission using the longest length waveguide as a worst-case scenario to confirm performance equivalence to the predicate.

Technological Characteristics

Hollow, semi-rigid light-conducting tube. Wavelengths: 10.6 µm (CO2) and 0.6328 µm (HeNe). Connector: 905 SMA. Dimensions: Core diameters 300-750 µm; lengths 60-200 cm. Accessories: Handpieces with polished metal surfaces for beam deflection, cleaving/cutting tools. Compatible with external gas purge systems (2 L/min, 4.5 psi).

Indications for Use

Indicated for patients undergoing open, laparoscopic, or endoscopic surgical procedures requiring soft tissue ablation, vaporization, excision, incision, or coagulation, specifically including ENT surgery. Compatible with CO2 lasers featuring a 905 SMA connector.

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

• CO2 Laser WaveGuide (K921671)

Submission Summary (Full Text)

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# SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

K100384 (Premarket Notification [510(k)] Number)

APR 1 2 2010

### 1. Applicant

Lumenis Ltd. 13 Hayetzira Str. (POB 240) Yokneam Industrial Park Yokneam 20692 Israel

Corresponding Official:

| Name: | Ahava Stein |
|----------|------------------------------------------|
| Title: | Regulatory Consultant |
| Address: | A. Stein - Regulatory Affairs Consulting |
| | Beit Hapa'amon (Box 124) |
| | 20 Hata'as St. |
| | 44425 Kfar Saba |
| | ISRAEL |
| Tel: | [phone] |
| Fax: | [phone] |

#### 2. Device Name

| Device Name: | CO2 Laser WaveGuide |
|-----------------------------------|----------------------------------------------------|
| Device trade or proprietary name: | FiberLase CO2 Laser WaveGuide |
| Common Name: | CO2 Laser WaveGuide |
| Classification Name: | Laser Surgical Instrument, 21 CFR Section 878.4810 |

### 3. Predicate Devices

The modified CO2 Laser WaveGuide is substantially equivalent to the following device:

| Device | Manufacturer | 510(k) No. |
|---------------------|-------------------------------------------|------------|
| CO2 Laser WaveGuide | Surgilase Inc. (acquired by Lumenis Ltd.) | K921671 |

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### 4. Intended Use

The CO2 Laser WaveGuide Delivery System is intended for use in open and laparoscopic surgical procedures for ablation, vaporization, excision, and coagulation of soft tissue.

#### 5. Description of the Device

The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end.

The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table:

| Core diameter [µm] | Outer diameters [µm] | Lengths [cm] |
|--------------------|----------------------|-------------------|
| 300 | 700, 800 | 60, 100, 150 |
| 500 | 900, 1040 | 60, 100, 150, 200 |
| 750 | 1200, 1400 | 100, 150, 200 |

Table 1 - CO2 Laser WaveGuide Dimensions

The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection

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with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.

### 6. Performance Testing

The modified waveguide and new handpieces were bench tested to establish percent transmission using the longest length fiber optic waveguide as the worse case test scenario.

### 7. Technological Characteristics Compared to Predicate Device

The technological characteristics of the modified device, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the new CO2 Laser WaveGuide are substantially equivalent to the previously cleared CO2 Laser WaveGuide cited above.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black against a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 1 2 2010

Lumenis Ltd. % A. Stein Regulatory Affairs Consulting Ltd. Ms. Ahava Stein, Regulatory Consultant Beit Hapa'amon (Box 124) 20 Hata'as St. Kfar Saba 44425, Israel

Re: K100384

Trade/Device Name: CO2 Laser WaveGuide 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: March 25, 2010 Received: April 05, 2010

Dear Ms. Stein:

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

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Page 2 - Ms. Ahava Stein

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 1 - INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K100384

Device Name:

FiberLase CO2 Laser WaveGuide

Indications for use: The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.

Prescription Use V (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100384