ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE

K112166 · W and R Investments Dba Laser Engineering · GEX · Oct 21, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112166
• Device Name: ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
• Applicant: W and R Investments Dba Laser Engineering
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

Device Story

UltraLase Flexible CO2 Laser Waveguide is a laser energy delivery system; consists of flexible silica capillary with reflective inner coating; protected by plastic sleeve; proximal end features fiber optic connector (905 SMA or 953 ST). Operates at 10.6µm wavelength; laser energy coupled via focusing lens; energy travels via multiple internal reflections to distal end for tissue application. Used in OR/clinical settings by surgeons; compatible with various CO2 lasers and handpieces (e.g., TTI Medical ACCU-Beam). Inert purge gas (helium) recommended for cooling and debris clearance. Single-use, sterile device. Facilitates precise soft tissue surgery; enables access in open and endoscopic procedures.

Clinical Evidence

Bench testing only. Performance testing established transmission bandwidth and percent transmission.

Technological Characteristics

Flexible silica capillary waveguide; reflective inner coating; 10.6µm wavelength transmission; 300µm to 750µm core diameters; 905 SMA or 953 ST connectors; sterile, single-use; inert gas purge system for cooling/debris management.

Indications for Use

Indicated for use with CO2 laser systems for incision, excision, ablation, vaporization, and coagulation of soft tissues in general, plastic, neuro, ophthalmic, oral, ENT, podiatric, gynecological, and urological surgery. Suitable for open and endoscopic procedures. Patient population is dependent on the cleared indications of the host laser system.

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

• FiberLase CO2 Laser Waveguide (K100384)
• SureGuide CO2 Laser Beam Delivery System (K992472)
• Beam Path CO2 Mark III WaveGuide Fiber (K070157)

Submission Summary (Full Text)

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OCT 2 1 2011

:

# SECTION 5 - 510(K) SUMMARY

### Applicant:

K112166

રુદ્યા બ ૩

W and R Investments, LLC d/b/a Laser Engineering 113 Cedar Street Suite S5 Milford, MA 01757 Tel: [phone]

Contact Person: Robert I. Rudko, Ph.D. Chief Scientist [e-mail]

Date Prepared: July 19, 2011

#### Device Name:

CO2 Laser Waveguide

Proprietary Name: Classification Name: Classification: Product Code:

UltraLase Flexible CO2 Laser Waveguide Laser Surgical Instrument 878.4810 GEX

#### Predicate Devices:

The UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to the following devices:

| Device | Manufacturer | 510(k) No. |
|---------------------------------------------|-----------------|------------|
| FiberLase CO2 Laser Waveguide | Lumenis Ltd | K100384 |
| SureGuide CO2 Laser<br>Beam Delivery System | Clinicon Corp. | K992472 |
| Beam Path CO2 Mark III<br>WaveGuide Fiber | OmniGuide, Inc. | K070157 |

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K112166 Pg 2 of 3

#### Device Description:

The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.

| Core Dia. (µm) | Outer Dia. (µm) | Lengths (cm) |
|----------------|-----------------|---------------|
| 300 | 750 | 100, 150 |
| 500 | 850 | 100, 150, 200 |
| 750 | 1200 | 100, 150, 200 |

It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.

The waveguides delivery systems are supplied sterile for single use.

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K112166 pg 3 of 3

#### Indications for Use:

The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

## Technological Characteristics Compared to Predicate Device:

After reviewing the technological characteristics (overall design, mechanism of action, mode of operation and performance characteristics) and the indications for use, it has been determined by Laser Engineering that the UltraLase Flexible CO2 Laser Waveguide is substantially equivalent to existing legally marketed devices.

### Performance testing:

The UltraLase Flexible CO2 Laser Waveguides are bench tested to establish transmission bandwidth, and percent transmission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird-like figure.

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

OCT 2 1 2011

W and R Investments, LLC d/b/a Laser Engineering % Robert I. Rudko, Ph.D. 113 Cedar Street, Suite S5 Milford, Massachusetts 01757

Re: K112166

Trade/Device Name: UltraLase Flexible 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: July 19, 2011 Received: July 28, 2011

Dear Dr. Rudko:

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 Foond, Or ug, 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 contractly and warranties. We remind you; however, that device labeling must be truth to bond not misleding.

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.

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Page 2 - Robert I. Rudko, Ph.D.

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 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 vours,

Erin Keith

forMark 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 4 - INDICATIONS FOR USE STATEMENT

K112166 510(k) Number: UltraLase Flexible CO2 Laser Waveguide Device Name: Indications for Use:

The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

Over-The-Counter Use Prescription Use x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) a management and consistence and the manufactures and the commended the seasonal commended the sense comments of

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.M. Kuth

(Division Sign-Off) Division of Surgical " it bedie, and Restorative Device

510(k) Number K112166