PILOT DIODE LASER, MODEL 002-00139

K100143 · CAO Group, Inc. · GEX · Aug 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100143
• Device Name: PILOT DIODE LASER, MODEL 002-00139
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pilot Diode Laser is indicated for the procedures of 1) Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery. And 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.

Device Story

Pilot Diode Laser delivers 810nm laser energy to human soft tissue for surgical procedures and therapeutic pain relief. Device utilizes solid-state diodes to generate energy, transmitted via proprietary optical fiber system to surgical site. Handpiece includes disposable single-use tip; activation controlled by foot-actuated switch. Features include 630nm aiming beam, adjustable power output, and continuous or pulse delivery modes. Used by clinicians in various surgical specialties (e.g., dentistry, dermatology, general surgery). Healthcare providers use laser to perform tissue procedures or apply topical heat for pain relief; output affects tissue via thermal energy. Benefits include precise tissue interaction and non-invasive pain management.

Clinical Evidence

Bench testing only. Device demonstrated compliance with 21 CFR 1040.10 and 1040.11, and IEC 60601-1 constructional requirements. Performance testing confirmed delivery of laser energy levels required for intended surgical and therapeutic pain relief applications. No clinical data presented.

Technological Characteristics

Solid-state diode laser; 810nm wavelength; max 9W output. Fiber-optic delivery system with disposable single-use tips. 630nm aiming beam. Foot-actuated switch. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, UL60601-1, 47 CFR 15/18, ETSI 301-489-1. Continuous and pulse delivery modes.

Indications for Use

Indicated for patients requiring soft tissue surgical procedures (lesion removal, excision, incision, vaporization, ablation, hemostasis, photocoagulation) across various medical specialties, or patients seeking temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasms, and increased local blood circulation.

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

• Velure Family of Diode Lasers (K063396)
• DenLaser 800 Plus (K062619)
• THOR VR Single Diode Laser Treatment Probe (K070024)

Submission Summary (Full Text)

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K 100143

## 510(k) Summary of Safety and Effectiveness

CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: [phone] Fax: [phone] AUG 1 3 2010

く

Robert Larsen, Preparation Date: July 16, 2010

Device Name:

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| Trade Name: | Pilot Diode Laser |
|-------------------------|-----------------------------------|
| Common Name: | 810nm Diode Laser |
| Product Classification: | Powered Laser Surgical Instrument |

# Legally Marketed Predicate Devices for Substantial Equivalence:

Velure Family of Diode Lasers, manufactured by Lasering S.R.L. (K063396)

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

THOR VR Single Diode Laser Treatment Probe, manufactured by Thor International (K070024)

# Rationale for Substantial Equivalence:

The aforementioned laser devices and their accompanying delivery systems share similar indications for use on soft tissue with the submitted device for cutting soft tissue, similal indications for use on son took too will are therapy for soft tissue relaxation and temporary relief of pain. The predicate devices and submitted device share similar allo telliporary rener of pain. The prounded and laser delivery method. The design leatures including warelengan, of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output montoning. The devices share similar applications to soft tissue and indications for use.

# Description of Submitted Device:

The Pilot Diode Laser is a device for delivering laser energy to human soft tissue The Pliot Drocedures and treatments. This energy is generated by solidfor a variety of surgical procedures and treaments. The councy of laser energy at 810 ±

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20nm for a maximum of 9 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary 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 option.

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 Pilot Diode Laser system:

The Pilot Diode Laser is indicated for the procedures of

- 1) Removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
And

- 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.
# Technological Characteristics and Substantial Equivalence:

The Velure Family of Diode Lasers 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 635nm aiming beam and features oners's that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emission with pulse emissions adjustable from 0.1 - 20 Hz. The maximum output of the working beam is 15 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 Surgical site: The system and Isation beam, and switching between a continuous anow for adjusting the carpar of the device features a wireless foot switch for actuating of pursed mode not The maximum output of the working beam is 5 watts.

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The THOR VR Single Diode Laser Treatment Probe uses solid state diodes to generate laser energy in the 810nm range. This system employs direct emissions from a handpiece containing the laser diode to transmit laser energy to the surgical site. The system features controls that allow for adjusting the pulse rate of the beam from 2.5 -20,000 Hz. The maximum output of the unit is 0.45 watts.

#### Conformity to Standards:

The Pilot 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 the entirety of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, UL60601-1, 47 CFR 15 and 18, and ETSI 301-489-1.

### Performance Data

The Pilot Diode Laser tested as compliant with 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 2001 and constructional requirements of IEC 60601-1. This device was tested and found to deliver laser energy necessary for the temporary relief of minor muscle and joint pain, etc. as described in the device's Indications for Use. The device was tested and passed CAO Group internal requirements for construction and performance.

### Conclusion

The Pilot Diode Laser 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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### 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the right.

#### Public Health Service

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

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

AUG 1 3 2010

Re: K100143

Trade/Device Name: Pilot 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 09, 2010

Received: August 13, 2010

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.

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Page 2 - Mr. Robert K. Larsen

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 (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,

Sincerely yours,

Mark M. Millhusan

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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K100143

### Indications for Use

AS 1 8 2010

510(k) Number (if known):

Device Name: Pilot Diode Laser

Indications For Use:

The Pilot Diode Laser is indicated for the procedures of

- 1) Removal of Iesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the medical fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, general surgery, urology, gynecology, and plastic surgery.
And

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ryden formxm

(Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100143