AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM

K042439 · Diamond Age Systems, Inc. · GEX · Oct 7, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042439
• Device Name: AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
• Applicant: Diamond Age Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 7, 2004
• 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 coaqulation 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

CO2 surgical laser system; utilizes 10.6 µm wavelength laser for soft tissue surgery. Components include power supply, cooling system, laser head, articulated arm, handpiece, microcomputer, and control panel. Operated by clinicians in various surgical settings. Laser energy delivered via handpiece to target tissue for incision, excision, ablation, vaporization, or coagulation. Microcomputer manages system parameters via control panel. Benefits include precise tissue interaction for diverse surgical applications.

Clinical Evidence

Bench testing only. Compliance with international safety standards (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2) and US federal performance standards (21 CFR 1040.10, 21 CFR 1040.11) for Class IV laser products.

Technological Characteristics

CO2 laser system; 10.6 µm wavelength. Components: power supply, cooling system, sealed CO2 laser head, articulated arm, handpiece, microcomputer. Class IV laser product. Complies with IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2. Standalone system.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues (including intraoral) across multiple 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

• Deka Smart CO2 laser (K031224, K031440)
• Lumenis LX-20 CO2 Surgical Laser System (K896478, K953074, K960475)

Submission Summary (Full Text)

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

#### 1. Submitted by:

K042439

Diamond Age Systems, Inc. 3775 South Laurel Way Chandler, AZ 85249 Phone: [phone]

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

Date Prepared: 29 August 2004

#### 2. Device Name

Trade/Proprietary Name: Common/Usual Name: Classification Name:

Azurvt Model CTL 1401. CO2 Surgical Laser System General Surgical Laser System Laser Instrument, Surgical, Powered (per 21 CFR 878.4810)

#### 3. Predicate Device:

The Azuryt Model CTL 1401, CO2 Surgical Laser System is substantially equivalent to other laser systems on the market, such as the Deka Smart CO2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO2 Surgical Laser System, cleared under K896478, K953074, and K960475.

#### 4. Intended use of the device

The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coaqulation 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.

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#### Description of the Device 5.

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, microcomputer and control panel.

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

Like the predicate devices, the Azuryt Model CTL 1401 is a CO2 surgical laser system, utilizing a laser with a wavelength of 10.6 µm. 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 1401certifies that its device complies with the following international standards:

EN60825-1. IEC 60825-1. Safety of laser products - Part 1: Equipment classification, requirements and user's guide.

EN60601-2-22, IEC 60601-2-22, Medical Electrical Equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.

EN60601-1. IEC 60601-1. Medical Electrical Equipment - Part 1: General requirements for safety, as amended by amendment 1 (1991) and amendment 2 (1995).

EN60601-1-2, IEC 60601-1-2, Medical Electrical Equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests

The device 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 Laser Notice No. 50, dated 26 July 2001.

#### 8. Conclusions

Based upon the testing and comparison to the predicate devices, the Azuryt Model CTL 1401 has the same intended uses, with similar technological characteristics as the predicate devices. 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diamond Age Systems, Inc. c/o Mr. Ned E. Devine Entela. Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K042439

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: II Product Code: GEX Dated: September 21, 2004 Received: September 22, 2004

0C1 7 - 2004

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 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.

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Page 2 - Mr. Ned Devine

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in your le FDA finding of substantial equivalence of your device to a legally promated nevice 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 11 you attire 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 other general micronal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark A. Millerson

Celia M. Witten, Ph.D., M.D. 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): K042439

Device Name: 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)

for

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

510(k) Number K042439

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