CO2 LASER SYSTEM, MODEL C-LAS

K063698 · Clinicon Corp. · GEX · Mar 2, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063698
• Device Name: CO2 LASER SYSTEM, MODEL C-LAS
• Applicant: Clinicon Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties: Cosmetic Surgery . Dermatology . General Surgery . Gynecology . Head & Neck Surgery . Neurosurgery . Oral Surgery . Orthopedic Surgery . Otorhinolaryngology . Pediatric Surgery . Plastic & Reconstructive Surgery . Podiatry . Urology .

Device Story

Tabletop CO2 laser system; emits 10.6 micrometer laser light via RF-excited tube; 30-watt output power. Used by physicians in clinical settings for soft tissue cutting and coagulation. Input: electrical power; Output: laser energy delivered via focusing handpiece or diamond scalpel. Microprocessor-controlled console; operated via footswitch. Provides precise tissue ablation; benefits include controlled surgical cutting and coagulation. Compact design (12.5"x13"); utilizes flexible cable waveguide for beam transmission.

Clinical Evidence

Bench testing only. Performance characteristics verified via software test procedures and reports. No clinical data provided.

Technological Characteristics

CO2 sealed laser; 10.6 micrometer wavelength; 30W output power; continuous waveform (Gauss). Microprocessor-controlled console; machined aluminum construction. Flexible cable waveguide delivery system. Footswitch-activated. Class II device.

Indications for Use

Indicated for soft tissue cutting and ablation in patients undergoing procedures in cosmetic, general, plastic, reconstructive, pediatric, oral, orthopedic, and neurosurgery, as well as dermatology, gynecology, head & neck surgery, otorhinolaryngology, podiatry, and urology.

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

• CHRYS (20 Watt CO2 Laser) (K875338)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Certified Software Solutions, Inc. The logo consists of the letters "CSS" in a bold, stylized font. The letters are black and have a horizontal line design. Below the letters, the words "Certified Software Solutions, Inc." are written in a smaller, sans-serif font.

K063698

MAR 0 2 2007

# 510(k) Summary

| Submitter/Applicant Name: | Clinicon Corporation |
|---------------------------|-----------------------------------------------|
| Contact: | Fritz Brauer |
| Address: | 3025-A Industry Street<br>Oceanside, CA 92054 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Kim L. Bloom (CSS, Inc.) |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Date prepared: | December 11, 2006 |
| Trade name: | C_Las CO2 Laser System |
| Common name: | CO2 Laser System |
| Classification name: | II |

#### Substantial equivalence claimed to:

K 875338: CHRYS (20 Watt CO2 Laser, cleared on April 13, 1988. The CHRYS (20 Watt CO2 Laser was cleared as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.

#### Device Description

The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.

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# Intended Use

The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

- Cosmetic Surgery .
- Dermatology .
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery .
- Orthopedic Surgery .
- Otorhinolaryngology .
- Pediatric Surgery .
- Plastic & Reconstructive Surgery .
- Podiatry .
- Urology .

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# General Product Information

- 1. Product Names: A.R.C. CO2 Laser System
- 2. Regulatory Information
- Regulatory Section: 878.4810 a.
- Classification: Class II b.
- Product Code: GEX c.
- d. Panel: General & Plastic Surgery
- 3. Intended Use:
- Indication(s) for use: Please see page 9 and 12. a.
- b. Special conditions for use statement(s): N/A
- Special instrument requirements: N/A c.
- 4. Device Description: Please see 510k Summary page 8.
- 5. Standard/Guidance Document Referenced: Please see pages 20
- Performance Characteristics: Please see the Software Test Procedures and Test 6. Report.
- 7. System description: Please see the Operational's Manual.
- Product Safety Standards and Test Results: Please see Certificate of Conformity 8. attachment and Software Test Procedures.

#### Supporting specifications:

Please see attached validation documents (some of which may also be noted on the last page of this document):

- 1) Certificate of Conformity
- 2) Safety Risk Analysis
- 3) Software Requirements Specification
- 4) Software Test Procedures
- 5) Software Test Report
- 6) C-Las Brochure
- 7) C-Las Operator's Manual

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# Technological Similarities and Differences to Predicate

# Substantial equivalence claimed to:

K875338: CHRYS™ MODEL MED-MAX cleared on 04/13/1988 as a laser surgical instrument for use in general surgery as well as plastic surgery and in dermatology.

### Summary of technological characteristics:

The following table describes similarities between CO2 Laser, Model C-LAS and the California Laboratories CHRYSTM MODEL MED-MAX (the predicate).

| Similarities | | |
|-----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Item | Device | Predicate |
| Name | CO2 Laser, Model C-LAS | CHRYSTM MODEL MED-<br>MAX by California<br>Laboratories (K875338) |
| Intended use | Intended to be used by<br>physicians to cut and<br>coagulate wounds during<br>surgery. | Intended to be used by<br>physicians to cut and<br>coagulate wounds during<br>surgery. |
| Footprint | Compact<br>12.5"x 13" | Compact<br>15" by 20" |
| Laser | CO2 sealed | CO2 sealed |
| WaveLength | 10.6 micrometers | 10.6 micrometers |
| Mode | Continuous wave form<br>(Gauss) | Continuous wave form<br>(TEM00) |
| Accessories | Flexible Cable Waveguide | Articulated Arm<br>Waveguide |
| Output Power | About 30 Watts | About 30 Watts |
| Weight | 39.6 pounds | 45 pounds |
| Console | Microprocessor | Microprocessor |
| Laser Operation | Footswitch | Footswitch |

Based on the intended use and the use of laser technology for cutting and coagulation of wounds during surgery using a waveguide, the CO2 Laser is substantially equivalent to the California Laboratories CHRYS.

# 000011

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clinicon Corporation % Certified Software Solutions, Inc. Ms. Kim L. Bloom Sr. Software Quality Engineer 16787 Bernardo Center drive, Suite A-1 San Diego, California 92128

MAR 0 2 2007

Re: K063698 Trade/Device Name: CO2 Laser, Model C-LAS 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: February 14, 2007 Received: February 15, 2007

Dear Ms. Bloom:

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 reclassifial 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

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Page 2 - Ms. Kim L. Bloom

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,

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 yours,

Mark McMillan

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

(To be determined) 510(k) Number: Device Name: C Las CO2 Laser System

Indications for Use: The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties:

- Cosmetic Surgery .
- Dermatology .
- General Surgery .
- Gynecology .
- Head & Neck Surgery .
- Neurosurgery .
- Oral Surgery .
- Orthopedic Surgery ●
- Otorhinolaryngology t
- Pediatric Surgery ●
- Plastic & Reconstructive Surgery t
- Podiatry
- Urology

Prescription Use
(Per 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | L063968 |
|---------------|---------|
|---------------|---------|

| | 000012 |
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| | Page 12 of 20 |