Pilot Elite Diode Laser

K142225 · CAO Group, Inc. · GEX · Sep 12, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142225
• Device Name: Pilot Elite Diode Laser
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pilot Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue. 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Device Story

Pilot Elite Diode Laser delivers 810nm laser energy to oral soft tissue for surgical procedures and pain relief; also activates teeth whitening materials. Solid-state diodes generate energy; optical fiber system transmits energy to surgical site via metal handpiece with disposable single-use tip. Foot-actuated switch controls beam activation. Features include 630nm aiming beam, adjustable power output, and continuous or pulse delivery modes. Used in dental clinics by dentists/trained staff. Provides precise tissue interaction for excision/ablation; infrared emissions provide thermal therapy for pain relief. Benefits include controlled tissue removal, hemostasis, and accelerated whitening procedures.

Clinical Evidence

Bench testing only. Evaluation sample confirmed device met design criteria for essential performance, safety features, and functional requirements per 21 CFR 1010 and 21 CFR 1040.

Technological Characteristics

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

Indications for Use

Indicated for dental patients requiring oral soft tissue surgery (lesion removal, excision, incision, vaporization, hemostasis, photocoagulation, abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, removal of inflamed edematous tissue), temporary pain relief (minor muscle/joint pain, stiffness, arthritis, muscle spasm, increased circulation), and teeth whitening/bleaching.

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

• Pioneer Elite Diode Laser (K131059)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 12, 2014

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

Re: K142225

Trade/Device Name: Pilot Elite 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 4, 2014 Received: August 13, 2014

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 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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K142225

Device Name Pilot Elite Diode Laser

Indications for Use (Describe)

The Pilot Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1) The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue.

2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of means of topical elevated tissue temperature from infrared spectral emissions;

3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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: August 5, 2014

#### Device Name:

| Trade Name: | Pilot Elite Diode Laser |
|-------------------------|-----------------------------------|
| Common Name: | Soft Tissue Diode Laser |
| Product Classification: | Powered Laser Surgical Instrument |

# Legally Marketed Predicate Devices for Substantial Equivalence:

Pioneer Elite Diode Laser, manufactured by CAO Group, Inc. (K131059)

#### Rationale for Substantial Equivalence:

The aforementioned device has identical indications for use with that of the present device for excision, incision, ablation, photocoagulation, and infrared heating of tissue for temporary pain relief on soft tissue for a variety of procedures in dentistry. These devices also have an identical indication for a light source to activate tooth whitening materials and assist in tooth whitening procedures. The predicate device and submitted device have identical performance features including wavelength, power output, energy type, operating controls, and laser delivery method. The devices have identical methods of disinfection and sterilization. The devices have identical methods of control systems, safety features, and performance monitoring.

# Description of Submitted Device:

The Pilot Elite 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 the 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 incorporated into 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 Pilot Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:

- 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
- 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
- 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

#### Technological Characteristics and Substantial Equivalence:

The Pioneer Elite 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 ± 20mm 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, 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 incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

#### 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

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Edition 2 and IEC 60825-1 Edition 1.2. The device is designed in compliance to the entirety of IEC 60601-1: 2nd Edition, IEC 60601-1-2, and IEC 60601-1-4.

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