PROMETEY, MODEL G1-03

K062071 · Spectrum International · GEX · Sep 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062071
• Device Name: PROMETEY, MODEL G1-03
• Applicant: Spectrum International
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty. Laser Periodontal Procedures, including: Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Teeth Whitening Procedures, including: Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.

Device Story

PROMETEY is a soft tissue diode laser system for oral cavity surgical procedures. Device uses solid-state laser diodes to generate 810 nm wavelength power (max 3 Watts). Laser energy is delivered to treatment site via fiber optic cables (200, 300, or 400 um core diameters) housed in a metal handpiece with disposable tips. System includes a 650 nm aiming beam and a foot-switch for power activation. Operated by dental professionals in a clinical setting. Front-panel keypad allows selection of continuous or pulsed operation modes. Laser energy facilitates incision, excision, vaporization, ablation, and coagulation of soft tissues, as well as periodontal debridement and light activation for teeth whitening. Benefits include precise tissue management and hemostasis during dental procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by comparison of technical specifications, design features, and intended use to legally marketed predicate devices.

Technological Characteristics

Solid-state diode laser; 810 ± 10 nm wavelength; max 3W power; continuous and pulsed modes; 630-650 nm aiming beam (2 mW); fiber optic delivery (200/300/400 um); fan/air cooled; 100-240 VAC power; digital emission control.

Indications for Use

Indicated for dental patients requiring oral soft tissue surgery (incision, excision, ablation, coagulation), periodontal procedures (curettage, debridement), or laser-assisted 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 2.4G (K050453)
• LaserSmile (K030539)
• SoftLase (K021227)

Submission Summary (Full Text)

{0}------------------------------------------------

K 062071

# 510(k) Summary of Safety and Effectiveness Information

| Company: | Spectrum International, Inc.<br>2643 Pleasant Hill Road<br>Pleasant Hill, CA 94523<br>Phone / fax: [phone] |
|------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | George I. Bekov, President<br>Phone: [phone], fax: [phone] |
| Preparation Date: | July 17, 2006 |
| Device Name: | |
| - Trade name: | PROMETEY TM |
| - Common name: | Soft tissue diode laser |
| - Classification name: | Laser instrument, Surgical, Powered |
| - Product code: | GEX |

## Legally Marketed Predicate Devices for Substantial Equivalence:

| - | K050453 | Odyssey 2.4G | by Ivoclar Vivodent, Inc. |
|---|---------|--------------|-----------------------------|
| - | K030539 | LaserSmile | by BioLase Technology, Inc. |
| - | K021227 | SoftLase | by ZAP Lasers, LLC |

#### Description of Submitted Device:

The PROMETEY ™ diode laser system is a device for delivering laser power to treated surfaces within oral cavity. This power is produced by solid-state laser diodes, which provide a consistent generation of laser power in 810 ± 10 nm spectral region with maximum power of 3 Watts. The laser power is delivered to the treatment site by means of fiber optic cables available in 400, 300 and 200 um core diameters. These cables provide safe transmission of laser power to the surgical site without creating undue risk to a patient or operatory staff by errant or collateral laser emissions. The device features front-panel keypad used to activate 650 nm aiming beam, set power output and select continuous or pulsed operation mode.

The distal end of delivery fiber cable is contained within a metal handpiece with a disposable tip /cannula. A standard foot-switch controls initiation /termination of laser power from the delivery fiber.

## Intended Use of PROMETEY Soft Tissue Diode Laser:

The device is intended to be used for a variety of surgical procedures in the oral cavity:

## Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision,

SEP 2 8 2006

{1}------------------------------------------------

Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.

## Laser Periodontal Procedures, including:

Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

### Teeth Whitening Procedures, including:

Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.

## Technological Characteristics of Submitted and Predicate Diode Lasers and Substantial Equivalence:

| Feature | Prometey | Odyssey 2.4G | LaserSmile | SoftLase |
|-----------------------|--------------------------------------|----------------------------------|---------------------------------|----------------------------------|
| 510(k) Number | This application | K050453 | K030539 | K021227 |
| Wavelength | $810 \pm 10$ nm | $810\pm 20$ nm | 810 nm | $808 \pm 5$ nm |
| Max Power | 3 Watts | 5 Watts | 10 Watts | 3.5 Watts |
| Operation mode | Continuous<br>wave<br>and pulsed | Continuous<br>wave<br>and pulsed | Continuous wave<br>and pulsed | Continuous<br>wave<br>and pulsed |
| Pulse control | Digital<br>emission control | Digital<br>emission control | Digital<br>emission control | Digital<br>emission control |
| Laser<br>power source | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state diode |
| Aiming beam laser | 630-650 nm, 2 mW | 630-650 nm, 3 mW | 630-670 nm, 5 mW | 650nm, 5 mW |
| Delivery system | Multi-mode fiber<br>400, 300, 200 um | Multi-mode fiber<br>400 um | Multi-mode fiber<br>1000-300 um | Multi-mode fiber<br>600, 400 um |
| Power<br>requirements | 100-240 VAC, 50-<br>60Hz, 0.5 A | 100-240 VAC, 50-<br>60Hz, 1.5 A | 100-240 VAC, 50-<br>60Hz, 1.5 A | 100-240 VAC, 50-<br>60Hz, 1.0 A |
| Cooling system | Fan / air cooled | Fan / air cooled | Fan / air cooled | Fan / air cooled |

#### Comparison Table

The aforementioned diode laser devices and their delivery systems share similar indications for use in oral environment, similar design features including wavelength, operating controls, and laser power delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications except for maximum power output, which is the lowest for Prometey laser but is still enough to perform all Indications for Use since their laser power requirements are below 3 Watts.

{2}------------------------------------------------

## Summary Basis of Equivalence:

There are no unique applications, indications for use, materials or specifications presented herein. Evidence of substantial equivalence has been demonstrated through:

- The PROMETEY ™ intended use and indications for use were previously cleared by . FDA for the predicate devices.
- The technical characteristics of Prometey diode laser are similar to those of cleared . Odyssey 2.4G, LaserSmile and SoftLase diode laser systems.
- Laser power output values of Prometey are well within previously cleared values of . predicate dental laser systems as described.
- The predicate devices and other previously FDA cleared diode laser systems with . similar power outputs have a proven safety and effectiveness in the treatment of the claimed indications.
- Safety and performance testing. .

Therefore, the PROMETEY ™ soft tissue diode laser system is substantially equivalent to its predicate devices cited above and raises no new safety and/or effectiveness issues. The device is designed to fully comply with relevant federal and international safety and performance standards.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 2006

Spectrum International, Inc. % Mr. George I. Bekov President 2643 Pleasant Hill Road Pleasant Hill, California 94523

Re: K062071

Trade/Device Name: PROMETEY™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 17, 2006 Received: July 24, 2006

Dear Mr. Bekov:

This letter corrects our substantially equivalent letter of September 28, 2006.

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 (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.

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); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Mr. George I. Bekov

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K 86 207 PROMETEY TM

Device Name:

4.

Indications for Use:

Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

Excision and Incision Biopsies. Hemostasis and Coagulation. Treatment of canker sores. herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty.

### Laser Periodontal Procedures, including:

Laser soft tissue curettage. Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility).

#### Teeth Whitening Procedures, including:

Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

and /or

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

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Mark N. Milken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K062071

Page 1 of 1