Sterling Supreme Diode Laser

K181614 · CAO Group, Inc. · GEX · Sep 10, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K181614
• Device Name: Sterling Supreme Diode Laser
• Applicant: CAO Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 10, 2019
• 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

Solid-state diode laser generates 810nm (±20nm) energy; max 3W output. Energy delivered via optical fiber system to metal handpiece with disposable tip. Foot-actuated switch controls beam activation. Includes 630nm aiming beam; adjustable power; continuous or pulse delivery modes. Used by dental professionals in clinical settings for soft tissue surgery, pain relief, and teeth whitening. Device provides thermal energy to tissue; clinician directs laser to target site. Benefits include precise tissue management and therapeutic heat for pain relief. Modification involves providing tips non-sterile; requires end-user liquid chemical sterilization.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed that liquid chemical sterilization of tips achieves log 6 bioburden reduction and that rinsing adequately removes residual sterilant. No clinical data provided.

Technological Characteristics

Solid-state diode laser; 810nm wavelength; 3W max output. Optical fiber delivery system. Metal handpiece with disposable tips. Foot-actuated switch. Complies with 21 CFR 1040.10/1040.11, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for dental/oral soft tissue procedures (lesion removal, excision, vaporization, hemostasis, etc.), temporary relief of minor muscle/joint pain/stiffness/arthritis, and light-activated teeth whitening. For prescription use.

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

• Sterling Supreme Diode Laser (K171986)

Submission Summary (Full Text)

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September 10, 2019

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

Re: K181614

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 Dated: June 8, 2018 Received: June 19, 2018

Dear Robert 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya Acting Assistant Director Light Based Energy Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181614

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.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary K181614

## Applicant Information:

| Company Name: | CAO Group, Inc. |
|-------------------|-----------------------------------------------------------|
| Company Address: | 4628 West Skyhawk Drive<br>West Jordan, Utah 84084 U.S.A. |
| Company Phone: | 1-801-256-9282 |
| Company Fax: | 1-801-256-9287 |
| Contact Person: | Robert K. Larsen |
| Preparation Date: | September 9, 2019 |

### Device Name:

| Trade Name: | Sterling Supreme Diode Laser |
|---------------------------|------------------------------|
| Common Name 1: | Soft Tissue Diode Laser |
| Product Code 1: | GEX |
| Regulation 1: | 878.4810 |
| Product Classification 1: | Class II |

### Legally Marketed Predicate Devices for Substantial Equivalence:

Sterling Supreme Diode Laser, manufactured by CAO Group, Inc. (K171986)

### Description of Submitted Device:

The Sterling Supreme 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, 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.

### Indications for Use of the Submitted Device:

The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:

- 1) The removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular

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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.

## Rationale for Substantial Equivalence:

The submitted device is the exact same device as the predicate, excepting for labeling changes that are presented in this application. There is no change in the indications for use. There is no change in the materials of construction. There is no change in operating principle. A modification is presented in the submitted device wherein the single-use disposable applicator tips provided for the device shall not be delivered to the end-user in a sterile condition. The device instructions for use indicate suitable materials and method for the end-user to sterilize the tip prior to use. This change represents only a labeling change to the device, and the intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

### Performance Data:

## ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY

The Sterling Supreme 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 is designed in compliance to the entirety of IEC 60601-1: 3° Edition, IEC 60601-1-2, and IEC 60601-1-6.

### PERFORMANCE BENCH TESTING

No new risks or concerns regarding device performance are raised in modifying the device to provide the single-use tips to the market in a non-sterile state. No performance characteristics or specifications of the device are modified.

### BIOCOMPATIBILITY

There are no modifications to the materials used in the device. Risk assessment activities demonstrate that presenting the single-use tips to the end-user in a non-sterile state does not introduce any increased risks or concerns so long as provided instructions for use are followed relative to processing the tips by the end-user prior to use.

### END-USER STERILIZATION

Verification and validation testing indicate that treatment of the tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden, without adversely impacting the performance or specifications of the tip. Verification tests show that rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip.

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## Conclusion:

The modifications to the Sterling Supreme Diode Laser wherein the single-use tips are delivered to the end-user in a non-sterile condition do not present any new concerns over safety and effectiveness of the device. The modifications consist only of changes to the device labeling and instructions for use for the end-user to be aware of the present condition of the tips and to properly prepare the tips for use. All other aspects of the device, including indications for use, are not affected by this change.