Sterling Supreme Diode Laser

K171986 · CAO Group, Inc. · GEX · Sep 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171986
• Device Name: Sterling Supreme Diode Laser
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterling Supreme 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 tissues 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 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

Sterling Supreme Diode Laser delivers 810nm infrared laser energy to soft tissue for dental/oral procedures. Solid-state AlGaAs diodes generate energy; optical fiber transmits energy through a handpiece assembly to a single-use disposable tip. Target tissue absorbs energy, converting it to heat for hemostasis, ablation, or vaporization. Device features color LCD touchscreen, 650nm aiming beam, and wireless foot-actuated switch (2.40-2.48 GHz). Used in dental clinics by practitioners. Factory-established presets available for common procedures; user-definable settings allow saving preferences. Benefits include precise tissue management and therapeutic heating for pain relief.

Clinical Evidence

Bench testing only. Evaluation included final assembly inspection (QAC-OP0298) and main/safety specification verification testing. Results demonstrate the device meets all labeled performance specifications.

Technological Characteristics

AlGaAs diode laser; 810±10nm wavelength; 0.1-3.0W output; 650±20nm aiming beam. Delivery via sheathed silica quartz fiber. Handpiece: stainless steel stem, anodized aluminum sleeve. Wireless foot pedal (IEEE 802.15.4, 2.40-2.48 GHz). Cooling: heatsink/fan. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1.

Indications for Use

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

• Precise SHP Diode Laser (K123443)

Submission Summary (Full Text)

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

September 22, 2017

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

Re: K171986

Trade/Device Name: Sterling Supreme 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: June 26, 2017 Received: July 3, 2017

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 Actinclude 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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free 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" (21 CFR 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

# Jennifer R. Stevenson -S3

For 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)

#### K171986

Device Name Sterling Supreme Diode Laser

Indications for Use (Describe)

The Sterling Supreme 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 tissues 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 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name, there is a thin red line, and below that, the text "Easier · Faster · Better™" is displayed in a smaller font size.

West Inrdrin III 8408

301.256.9282 [phone]
877.877.9778 [toll free]
301.256.9287 [fax]

## 510(k) Summary

Prepared By: Robert K. Larsen Preparation Date: September 21, 2017

### Contact Information:

| Contact Name: | Robert K. Larsen |
|------------------|--------------------------------------------------|
| Contact Title: | Regulatory Affairs Manager |
| Address: | 4628 West Skyhawk Drive<br>West Jordan, UT 84084 |
| Contact Phone #: | 801-256-9282 |
| Contact Email: | [e-mail] |

#### Device Name:

| Trade Name: | Sterling Supreme Diode Laser |
|---------------------------|-------------------------------------------------|
| Common Name: | Soft Tissue Diode Laser |
| Product Code 1: | GEX |
| Regulation 1: | 878.4810 |
| Product Classification 1: | Powered Laser Surgical Instrument<br>Class II |
| Product Code 2: | ILY |
| Regulation 2: | 890.5500 |
| Product Classification 2: | Lamp, Infrared, Therapeutic Heating<br>Class II |

#### Legally Marketed Predicate Devices for Substantial Equivalence:

Precise SHP Diode Laser, manufactured by CAO Group, Inc. (K123443)

#### Rationale for Substantial Equivalence:

The submitted device and identified predicate device share exactly identical indications for use in dentistry and oral soft tissue procedures:

- 1) The removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues 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 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.

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4628 W. Skyhawk Drive West Jordan, UT 84084 www.caogroup.com

The submitted device and predicate device shares including emission sources, operating controls, key constructional components, and materials of construction. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output, emission wavelength, and energy type.

#### Description of Submitted Device:

The Sterling Supreme Diode Laser is a device for delivering laser energy to human soft tissue for a variety of dental and oral 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 fully ensheathed within a coated steel coil terminated in a handpiece assembly, 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 target tissues absorb the laser energy converting it to heat. Depending on the intensity or power output of the laser, the heat so generated can cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factoryestablished presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.

Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a wireless foot-actuated switch.

### Description of Predicate Device:

The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of dental and oral 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 fully ensheathed within a coated steel coil terminated in a handpiece assembly, 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 target tissues absorb the laser energy converting it to heat. Depending on the intensity or power output of the laser, the heat. so generated can cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factory-established presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.

Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a wireless foot-actuated switch.

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Image /page/5/Picture/0 description: The image shows the logo for CAO GROUP, INC. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name, there is a tagline that reads "Easier · Faster · Better™".

| 4628 W. Skyhawk Drive<br>West Jordan, UT 84084 | 801.256.9282 [phone]<br>877.877.9778 [toll free]<br>801.256.9287 [fax] |
|------------------------------------------------|------------------------------------------------------------------------|
| www.caogroup.com | |

#### Indications for Use of the Submitted Device:

The Sterling Supreme Diode Laser is indicated for use for -

- 1) The removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues 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 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: | | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | CAO Group, Inc. Sterling Supreme | CAO Group, Inc. Precise SHP |
| Working Beam<br>Output<br>Wavelength | 810±10 nm | 810±10 nm |
| Working Beam<br>Output Power | 0.1 - 3.0 watts | 0.5 - 3.0 watts |
| Aiming Beam<br>Output Power | < 3mW | < 3mW |
| Aiming Beam<br>Output<br>Wavelength | 650±20 nm | 650±20 nm |
| Laser Source | AlGaAs Diode | AlGaAs Diode |
| Laser<br>Activation | Wireless foot pedal<br>2.40 - 2.48 GHz, IEEE 802.15.4 Protocol | Wireless foot pedal<br>2.40 - 2.48 GHz, IEEE 802.15.4 Protocol |
| Pulse Control | Digital emission control<br>Fixed pulse duration of 0.05 seconds, 10Hz | Digital emission control<br>Selectable fixed pulse duration of 0.03, 0.05,<br>or 0.075 seconds, all at 10Hz |
| Cooling<br>Method | Heatsink / Fan air cooled | Heatsink / Fan air cooled |
| Electrical<br>Power Input<br>(System) | 100-240 VAC @ 47-63 Hz, 1.6A (switchable) | 100-240 VAC @ 47-63 Hz, 1.6A (switchable) |
| User Interface | Color LCD Touch Screen | Color LCD Touch Screen |
| Laser Delivery<br>System | Sheathed quartz optical fiber | Sheathed quartz optical fiber |
| Handpiece<br>design | Inner stem composed of stainless steel<br>permanently attached to the fiber cable;<br>Removable, sterilizable anodized aluminum<br>outer sleeve | Inner stem composed of stainless steel<br>permanently attached to the fiber cable;<br>Removable, sterilizable anodized aluminum<br>outer sleeve |
| Patient Contact<br>Articles | Single use disposable tip composed of silica<br>quartz, stainless steel, and ABS plastic | Single use disposable tip composed of silica<br>quartz, stainless steel, and ABS plastic |

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Image /page/6/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name is the tagline "Easier · Faster · Better™" in a smaller font size.

| 4628 W. Skyhawk Drive | 801.256.9282 [phone] |
|-----------------------|--------------------------|
| West Jordan, UT 84084 | 877.877.9778 [toll free] |
| www.caogroup.com | 801.256.9287 [fax] |

| | CAO Group, Inc. Sterling Supreme | CAO Group, Inc. Precise SHP |
|--------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| Energy emissions for select device presets | | |
| Curettage | 1.4 watts, Pulse, 30-second timer | 1.4 watts, 0.05 Pulse |
| Gingivectomy | 1.0 watts, continuous emission | 1.0 watts, continuous emission |
| Phototherapy - | 321 J/cm² | 321 J/cm² |
| Pain Relief | (2.0 watts, continuous emission, therapy tip, 5 | (2.0 watts, continuous emission, therapy tip, 5 |
| | minute exposure) | minute exposure) |
| Whitening | 900 1 | 900 1 |
| | (3 watts, Continuous, 5 minute total exposure) | (3 watts, Continuous, 5 minute total exposure) |
| Dimensions | 7.5″ x 5.5″ x 4″ | 5.5″ x 4.75″ x 2.375″ |
| Weight | 3.5 lbs | 4.0 lbs |
| 510(k) Number | Pending this application | K123443 |
| Indications for | The Sterling Supreme Diode Laser is indicated | The Pioneer Elite Diode Laser is indicated for |
| Use | for dentistry and oral soft tissue procedures | dentistry and oral soft tissue procedures of: |
| | of: | |
| | 1) The removal of lesions, excision, incision, | 1) The removal of lesions, excision, incision, |
| | vaporization, ablation, hemostasis, and | vaporization, ablation, hemostasis, and |
| | photocoagulation on soft tissues including | photocoagulation on soft tissues including |
| | abscess treatment, contouring, curettage, | abscess treatment, contouring, curettage, |
| | sulcular debridement, pulpotomy, | sulcular debridement, pulpotomy, |
| | frenectomy, gingivectomy, troughing, and | frenectomy, gingivectomy, troughing, and |
| | removal of inflamed edematous tissue; | removal of inflamed edematous tissue; |
| | 2) Temporary relief of minor muscle and joint | 2) Temporary relief of minor muscle and joint |
| | pain, stiffness, minor arthritis pain, muscle | pain, stiffness, minor arthritis pain, muscle |
| | spasm, temporary increase in local | spasm, temporary increase in local |
| | circulation, and temporary relaxation of | circulation, and temporary relaxation of |
| | muscles by means of topical elevated tissue | muscles by means of topical elevated tissue |
| | temperature from infrared spectral | temperature from infrared spectral |
| | emissions; | emissions; |
| | 3) Light activation of bleaching materials for | 3) Light activation of bleaching materials for |
| | teeth whitening and laser-assisted | teeth whitening and laser-assisted |
| | whitening/bleaching of teeth. | whitening/bleaching of teeth. |

To summarize the technological characteristics, the submitted device and the predicate device share the same technology of generating 810nm infrared laser energy via solid state diodes. The submitted and predicate devices share the same methods of delivering the laser energy through a silica quartz fiber to an affixed handpiece assembly. The devices share the same method of using a single-use disposable tip composed of the same materials for delivering the laser energy to the treatment site. The devices share functionality of a wireless footswitch to activate the 810nm laser energy, such wireless footswitches using the same wireless frequency and transmission technology. The devices share the same method of digital pulse control, with similar manner of fixed pulse width. The devices share the same indications for use. The devices share similar usage of color touchscreen technology as the user interface.

The devices differ in the physical shape of the devices differ in that the predicate uses an off-theshelf component as the touchscreen interface, while the submitted device uses an embedded color touchscreen interface.

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Image /page/7/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name, the text "Easier · Faster · Better" is written in a smaller font size.

4628 W. Skyhawk Drive
West Jordan, UT 84084
**www.caogroup.com**
801.256.9282 [phone]
877.877.9778 [toll free]
801.256.9287 [fax]

#### Conformity to Standar

The Sterling Supreme Diode Laser is designed to comply with the performance requirements of ANSI/AAMI ES60601-1:2005+A1 (Edition 3.0), AAMI/ANSI/ IEC 60601-1-2:2007 (Edition 3.0), IEC 60601-1-6:2013 (Edition 3.1), IEC 60601-2-22:2007 (Edition 3.1), and IEC 60825-1:2007 (Edition 2.0).

#### Performance Data:

Bench testing on an evaluation sample of the submitted device was performed consistent with internal requirements:

- . QAC-OP0298 - Final assembly inspection of Sterling Supreme Diode Laser
- Sterling Supreme Main and Safety Specification Verification Test ●

Results of these tests demonstrate the product meets the device's labeled specifications.

#### Conclusion:

The Sterling Supreme Diode Laser is substantially equivalent to the listed predicate. This device shares identical intended uses, identical operating principles, similar design features, and identical functional and performance characteristics.