PRECISE SHP DIODE LASER

K113472 · CAO Group, Inc. · GEX · Aug 30, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113472
• Device Name: PRECISE SHP DIODE LASER
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

Device Story

Precise SHP Diode Laser is a powered surgical instrument for dental soft tissue procedures. Device uses solid-state diodes to generate 810nm (± 20nm) laser energy; maximum 3W output. Energy delivered to surgical site via optical fiber system housed in metal handpiece with disposable single-use tips. Features include 630nm aiming beam; adjustable power settings; continuous or pulsed delivery modes. Operated by dentist in clinical setting via foot-actuated switch. Laser energy performs excision, incision, ablation, and hemostasis. Benefits include precise tissue removal and controlled coagulation during oral surgery.

Clinical Evidence

Bench testing only. Evaluation confirmed device met design criteria for essential performance, output requirements per 21 CFR 1010/1040, and correct operation of all safety features.

Technological Characteristics

Solid-state diode laser; 810nm ± 20nm wavelength; 3W max output. 630nm aiming beam. Fiber optic delivery system with disposable single-use tips. Foot-switch activation. Complies with 21 CFR 1040.10/1040.11, IEC 60601-1 (3rd Ed), IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for patients requiring oral soft tissue surgery, including gingivectomy, frenectomy, operculectomy, contouring, biopsy, troughing, ulcer/abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

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 Navigator Diode Laser (K062258)
• DenLaser 800 Plus (K062619)

Submission Summary (Full Text)

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K113472

# 510(k) Summary of Safety and Effectiveness

CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: [phone] Fax: [phone]

Prepared By: Robert K. Larsen, Preparation Date: November 15, 2011

#### Device Name:

| Trade Name: | Precise SHP Diode Laser |
|-------------------------|-----------------------------------|
| Common Name: | Soft Tissue Diode Laser |
| Product Classification: | Powered Laser Surgical Instrument |

## Legally Marketed Predicate Devices for Substantial Equivalence:

Odyssey Navigator Diode Laser, manufactured by Ivoclar Vivadent, Inc. (K062258)

DenLaser 800 Plus, manufactured by CAO Group, Inc. (K062619)

#### Rationale for Substantial Equivalence:

The aforementioned devices share similar indications for use with the present device for excision, incision, ablation, and photocoagulation on soft tissue for a variety of procedures in dentistry. The predicate devices and submitted device share 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.

#### Description of Submitted Device:

The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. 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 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site 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 630nm aiming beam,

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adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.

The working end of the delivery fiber is contained within a 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 Submitted Device:

The Precise SHP Diode Laser is indicated for the removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

#### Technological Characteristics and Substantial Equivalence:

The Odyssey Navigator Diode Lasers 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 emissions. The maximum output of the working beam is 3 watts.

The DenLaser 800 Plus 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 emissions. The maximum output of the working beam is 5 watts.

#### Conformity to Standards:

The Precise SHP Diode Laser is designed to comply with the performance requirements . of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated June 24, 2007. The device also complies with the recognized standards of IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2. The device also designed in compliance to the entirety of 1EC 60601-1: 3nd Edition, 1EC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.

#### Performance Data

Bench testing on an evaluation sample of the current device revealed that the device met the design criteria for essential performance, and satisfied the performance requirements

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indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly.

### Conclusion

The Precise SHP Diode Laser is substantially equivalent to the listed predicate devices without raising any new issues of safety or effectiveness. This device shares similar intended uses, operating principles, design features, and similar functional and performance abaracteristics. The device is designed to comply with relevant federal and international safety and performance standards.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

AUG 30 2012

CAO Group, Incorporated % Mr. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084

Re: K113472

Trade/Device Name: Precise SHP Diode Laser 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 20, 2012 Received: August 22, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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 that I Drines interes and regulations administered by other Federal agencies. You must

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#### Page 2 - Mr. Robert K. Larsen

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 yours,

FOR

Mark 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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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Melh R. Sella Lis mkn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113472
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