AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM

K062248 · North American Clinical Lasers, Ltd. · GEX · Aug 17, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062248
• Device Name: AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
• Applicant: North American Clinical Lasers, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.

Device Story

Azuryt Model CTL 1401 is a CO2 surgical laser system (10.6 um wavelength) used for soft tissue surgery. System components include power supply, cooling system, sealed CO2 laser head, articulated arm, handpiece, microcontroller, and control panel. Operated by physicians in clinical settings (e.g., OR, dermatology, dental clinics). Laser energy is delivered via articulated arm and handpiece to target tissue for incision, excision, ablation, vaporization, or coagulation. Microcontroller manages system parameters via control panel. Device provides surgical precision for various medical specialties. Benefits include controlled tissue interaction for diverse surgical applications.

Clinical Evidence

Bench testing only. No clinical data provided. Device compliance verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards, as well as 21 CFR 1040.10 and 1040.11.

Technological Characteristics

CO2 laser system; 10.6 um wavelength; Class IV laser. Components: power supply, cooling system, sealed CO2 laser head, articulated arm, handpiece, microcontroller. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, 21 CFR 1040.10/11.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues (including intraoral) across various surgical specialties including general, plastic, dental, oral/maxillofacial, dermatological, gastrointestinal, gynecological, ENT, aesthetic, neurosurgical, oculoplastic, orthopedic, pulmonary/thoracic, and urological procedures.

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

• Azuryt Model CTL 1401 (K042439)

Submission Summary (Full Text)

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K062248

## Premarket Notification [510(k)] Summary (per 21 CFR 807.92)

AUG 1 7 2006

#### Submitted by: 1.

North American Clinical Lasers, Ltd. 2755 S. Amcs Way Denver, CO 80227

| Contact Person: | Geoffrey D. Swank |
|-----------------|------------------------------|
| | Vice-President of Operations |
| | Phone: [phone] |
| | Fax: [phone] |

Date Prepared: 31 May 2006

#### 2. Device Name

| Trade/Proprietary Name: | Azuryt Model CTL 1401, CO2 Surgical Laser System |
|-------------------------|--------------------------------------------------------------|
| Common/Usual Name: | General Surgical Laser System |
| Classification Name: | Laser Instrument, Surgical, Powered<br>(per 21 CFR 878.4810) |

#### Predicate Device: 3.

The Azuryt Model CTL 1401, CO2 Surgical Laser System described in this submission is substantially equivalent to the Azuryt Model CTL 1401 cleared under K042439.

#### 4. Intended use of the device

The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.

#### 5. Description of the Device

The, Azuryt Model CTL 1401 CO2 Surgical Laser System is a CO2 laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller and control panel.

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### Summary of the technological characteristics of the device compared to the 6. predicate device.

The Azuryt Model CTL 1401 is a CO2 surgical laser system, utilizing a laser with a wavelength of 10.6 um. Each of these devices contains a power supply, a cooling system, a sealed CO2 laser head delivering a beam with a wavelength of 10.6 um, an arm to deliver the laser beam, a handpiece and a variety of accessories to address specific surgical needs.

#### 7. Testing

The manufacturer of the Azuryt Model CTL 1401 certifies that its device complies with the following international standards:

- IEC 60825-1, Safety of laser products Part 1: Equipment classification, . requirements and user's guide.
- . IEC 60601-2-22, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
- IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for . safety, as amended by amendment 1 (1991) and amendment 2 (1995).
- IEC 60601-1-2, Medical Electrical Equipment Part 1: General requirements for . safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests

The device is also complies with the European Medical Device Directive 92/42/EEC and the US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, except for deviations pursuant to Lascr Notice No. 50, dated 26 July 2001.

#### 8. Conclusions

Based upon the testing and comparison to the predicate devices, the Azuryt Model CTI. 1401 has the same intended uses, with the same technological characteristics as the device described in the previous submission. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 2006

North American Clinical Lasers, Ltd. % Intertek Testing Services Mr. Neil E. Devine, Jr. Senior Staff Engineer 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K062248

Trade/Device Name: Azuryt Model CTL 1401, CO2 Surgical Laser System 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: August 2, 2006 Received: August 3, 2006

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Neil E. Devine, Jr.

CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely Nours.

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Namc: Azuryt Model CTL 1401, CO2 Surgical Laser System

Indications For Use:

The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number k062248

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Azuryt CTL-1401