PIONEER ELITE DIODE LASER

K131059 · CAO Group, Inc. · GEX · Sep 13, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131059
• Device Name: PIONEER ELITE DIODE LASER
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer 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.

Device Story

Pioneer Elite Diode Laser delivers 810nm (±20nm) laser energy to oral soft tissue via optical fiber system; solid-state diode source; max 3W output. Features 630nm aiming beam; continuous or pulse delivery modes; user-definable settings. Operated by dental professionals using foot-actuated switch; metal handpiece with disposable single-use tip. Energy used for surgical procedures (excision, ablation, hemostasis), pain relief via infrared thermal effect, and tooth whitening activation. Clinical benefit: precise soft tissue management, pain relief, and efficient whitening. Device used in dental clinic setting.

Clinical Evidence

Bench testing only. Evaluation of device sample confirmed compliance with 21 CFR 1010 and 1040, and essential performance criteria. Safety features and functions verified as operating correctly.

Technological Characteristics

Solid-state diode laser; 810nm (±20nm) wavelength; 3W max output; 630nm aiming beam. Fiber optic delivery system; metal handpiece with 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, IEC 60601-1-2, and IEC 60601-1-4.

Indications for Use

Indicated for dental/oral soft tissue procedures (lesion removal, excision, incision, vaporization, ablation, hemostasis, photocoagulation, abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, removal of inflamed edematous tissue); temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation; and light activation of bleaching materials for teeth whitening.

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)
• Pilot Diode Laser (K100143)
• ezLase (K082938)

Submission Summary (Full Text)

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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: September 11, 2013

Device Name:

| Trade Name: | Pioneer Elite 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 for Ivoclar Vivadent, Inc. (K062258)

Pilot Diode Laser, manufactured by CAO Group, Inc. (K100143)

ezLase, manufactured by Biolase, Inc. (K082938)

#### Rationale for Substantial Equivalence:

The present device shares similar specific indications with the aforementioned devices as now specified:

- . Excision, incision, ablation, and photocoagulation (K062258)
- Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle o spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions (K100143)
- A light source to activate tooth whitening materials and assist in tooth whitening . procedures (K082938)

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.

SEP 1-3-2013

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#### Description of Submitted Device:

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 terminal 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 diode is completed by use of a foot-actuated switch.

#### Intended Uses of the Submitted Device:

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

- l) 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 Odyssey Navigator Diode Laser is a device for delivering laser energy to human oral soft tissue for a variety of surgical procedures and treatments. This energy is generated by solidstate 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 treatment 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.

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#### K131059

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.

The Pilot 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 treatment 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 9 watts.

The ezlase uses solid state diodes to generate laser energy in the 940nm range. This system uses a fiber delivery system to transmit laser energy to the treatment 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 7 watts.

#### Conformity to Standards:

The Pioneer Elite 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 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 Pioneer Elite 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 characteristics. The device is designed to comply with relevant federal and international safety and performance standards.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like bird with three curved lines representing its body and wings. The bird is oriented towards the upper right of the image. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 13, 2013

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

Re: K131059

Trade/Device Name: Pioneer 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. ILY Dated: August 22, 2013 Received: August 23. 2013

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 docs 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 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Robert K. 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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

# Peter D. Rumm -A

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

K131059 510(k) Number (if known):

Device Name: Pioneer Elite Diode Laser

The Pioneer 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.

Prescription Use AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden: Ja 2013.09.13 09:26:51 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

KI31050 510(k) Number _

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