DENLASER 800 PLUS

K061366 · CAO Group, Inc. · GEX · Jul 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061366
• Device Name: DENLASER 800 PLUS
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to be used for a variety of surgical procedures on soft tissue within the oral cavity. Dental, oral, and soft tissue surgery including: Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation

Device Story

DenLaser 800 Plus is an 810nm diode laser system for oral soft tissue surgery. Device generates laser energy via solid-state diodes (max 5W output); energy delivered to surgical site via proprietary optical fiber system with disposable single-use tips. System includes 630nm aiming beam; user-definable settings for power output and continuous or pulsed-mode emission. Operated by clinician via foot-actuated switch. Laser energy interacts with soft tissue to perform surgical tasks like excision, ablation, and coagulation. Benefits include precise tissue management and reduced collateral damage compared to traditional methods. Used in clinical dental settings.

Clinical Evidence

Bench testing only. Device complies with 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, 47 CFR 15/18, and ETSI 301-489-1. No clinical data provided.

Technological Characteristics

Solid-state diode laser; 810nm ± 20nm wavelength; 5W max output. Fiber optic delivery system with disposable tips. 630nm aiming beam. Foot-actuated switch. Compliance: 21 CFR 1040.10/1040.11, IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 60825-1:1993+A1+A2, 47 CFR 15/18, ETSI 301-489-1.

Indications for Use

Indicated for dental, oral, and soft tissue surgery in patients requiring procedures such as sulcular debridement, excision, biopsy, gingivectomy, gingivoplasty, lesion/tumor/fibroma removal, tissue retraction, aphthous ulcer treatment, gingival hyperplasia correction, crown lengthening, operculectomy, frenectomy, and photocoagulation.

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

• Odyssey 2.4G Diode Laser
• DenLaser 800 (CAO Group, Inc.)

Reference Devices

• Cynosure Accolade Laser

Submission Summary (Full Text)

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K061366

### 510(k) Summary of Safety and Effectiveness

CAO Group, Inc. 86863 South 700 West Sandy, UT 84070 Tel: [phone] Fax: [phone]

【JUL 1002006

Robert Larsen. Preparation Date: May 8, 2006

### Device Name:

Trade Name: DenLaser 800 Plus

Common Name: 810nm Diode Laser

Product Classification: Laser Instrument, Surgical

### Legally Marketed Predicate Devices for Substantial Equivalence:

Odyssey 2.4G Diode Laser

DenLaser 800. Manufactured by CAO Group, Inc.

# Cynosure Accolade Laser

### Rationale for Substantial Equivalence:

The aforementioned laser devices and their accompanying delivery systems share similar indications for use in the oral environment, similar design features including wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type. The devices share similar applications to soft tissue.

### Description of Submitted Device:

The DenLaser 800 Plus is a device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allow for the safe transmission of laser energy to the sire without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable

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630mm aiming beam, adjustable power output for both the working bearn and aiming beam, and continuous delivery or pulse delivery option.

The working end of the delivery fiber is contained within metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch --

### Intended Uses of the DenLaser 800 Plus diode laser system:

The device is intended to be used for a variety of surgical procedures on soft tissue within the oral cavity. See Indications for Use on page 2-1.

# Technological Characteristics and Substantial Equivalence:

The Odyssey 2.4G Diode Laser uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission. The device features a wireless foot switch for actuating the working beam. The maximum output of the working beam is 5 watts. - - -

The DenLaser 800 uses solid state diodes to generate laser energy in the 810mm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630mm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsedmode laser emission. The maximum output of the unit 5 watts.

The Cynosure Accolade Laser uses an excited Alexandrite crystal to generate a laser wavelength of 755nm. The system uses and optical fiber to deliver laser energy to the surgical site. The system also features a 635mm aiming beam. The system is used to apply laser energy to cutaneous and subcutaneous pigmentations, whether naturally occurring or artificially applied. The discolorations absorb the laser energy causing the discoloration to become altered such that the color is removed. The maximum output of the unit is 1.8J at a pulse width of 60 nanoseconds.

#### Performance Standards:

The DenLaser 800 Plus diode laser complies with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 2001. The device also complies with IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 60825-1:1993+A1+A2, 47 CFR 15 and 18, and ETSI 301-489-1.

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# Clinical Performance Data

See Part 7: Performance Data

# Conclusion

The DenLaser 800 Plus is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle. The letters "USA" are on the right side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 10 2006

CAO Group, Inc. % Mr. Robert Larsen Operations Director 8683 South 700 West Sandy, Utah 84070

Re: K061366

Trade/Device Name: DenLaser 800 Plus 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: May 8, 2006 Received: May 16, 2006

Dear Mr. Larsen:

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 complics 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 -- Mr. Robert Larsen

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 vours.

Hulut lemerno

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): | K 061366 |
|---------------------------|----------|
|---------------------------|----------|

Device Name: DenLaser 800 Plus

Indications For Use:

Dental, oral, and soft tissue surgery including:

Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation

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)

Hulbert Leeman

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

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