FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F

K083034 · Fotona D.D. · GEX · Feb 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083034
• Device Name: FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
• Applicant: Fotona D.D.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona XD Diode Laser System, and its accessories, are intended for use in Periodontology for Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket Oral Soft Tissue surgery for Gingivectomy Gingivoplasty Fibroma removal Treatment of Aphthous Ulcers Crown Lenghtening Frenectomy Papillectomy Photocoagulation Cosmetic Dentistry for Light activation for bleaching materials for teeth whitening Lasers-assisted bleaching/whitening of the teeth

Device Story

Fotona XD Diode Laser System is a semiconductor laser emitting 810 nm near-infrared light. Device operates in continuous wave or pulse mode (20 Hz to 10 kHz) with power output 250 mW to 7.0 W. System includes a 650 nm red diode aiming beam. Laser energy is delivered via optical fiber and handpiece to the treatment site. Used by dental professionals in clinical settings for soft tissue surgery and teeth whitening. Clinician directs laser beam to target tissue or bleaching material; laser energy facilitates tissue ablation, coagulation, or light-activation of whitening agents. Provides precise surgical control and therapeutic benefits for periodontal and cosmetic dental applications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Semiconductor laser diode; 810 nm wavelength; 650 nm aiming beam; continuous wave or pulse mode (20 Hz - 10 kHz); 250 mW - 7.0 W output power; optical fiber delivery system; Class II device.

Indications for Use

Indicated for patients requiring oral soft tissue surgical procedures (gingivectomy, gingivoplasty, fibroma removal, aphthous ulcer treatment, crown lengthening, frenectomy, papillectomy, photocoagulation, periodontal curettage) 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 Diode Laser (K050453)
• Opus 10 Dental Diode Laser System (K011769)

Submission Summary (Full Text)

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

KD.83034

Page (1) of (2)

FEB ~ 4 2009

## 5. 510(k) Summary

Submitter's Name:

Fotona d.d. Stegne 7 1210 Ljubljana, Slovenia Phone: [phone] + 386 5009 200 Fax: Stojan Trošt, QA&RA Manager Phone: + 386 1 5009 299 E-mail: stojan [e-mail]

Contact Person:

Date: October 8, 2008

Device Name: Trade name: Common name: Classification name:

Fotona XD Diode Laser System Diode Surgical Laser Instruments, Surgical, Powered, Laser 79-GEX

### DEVICE DESCRIPTION

The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.

### INTENDED USE

The Fotona XD Diode Laser System, and its accessories, are intended for use in

- Periodontology for
- Laser soft tissue curettage r
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Oral Soft Tissue surgery for
- Gingivectomy
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- Frenectomy
- Papillectomy
- Photocoagulation

510(k) Submission Fotona XD Diode Laser System / v2

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

KU8303X Page (1) of (2)

- Cosmetic Dentistry for
- Light activation for bleaching materials for teeth whitening -
- Lasers-assisted bleaching/whitening of the teeth -

### STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Fotona XD Diode Laser System shares the same indications for use, similar design and functional features with, and therefore Fotona d.d. believes that its Fotona XD Laser System is substantially equivalent to, the

a) Odyssey 2.4G Diode Laser (K050453) previously cleared for a variety of surgical procedures on soft tissue within the oral cavity;

b) Opus 10 Dental Diode Laser System (With Tooth Whitening Application) (K011769) previously cleared for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.

Details are provided in the Substantial Equivalence Discussion Section of this submission.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract eagle or bird-like figure.

#### Public Health Service

FEB - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fotona D.D. % Mr. Stojan Trost Stegne 7 Ljubljana Slovenia 1210

Re: K083034

Trade/Device Name: Fotona XD Diode Laser System 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: January 19, 2009 Received: January 23, 2009

Dear Mr. Trost:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.

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

This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N. Milburn

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

Enclosure

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

## 4. Indications for Use Statement

510(k) Number (if known):

# 083034

Device Name: Fotona XD Diode Laser System

Indications For Use:

### Periodontology

- Laser soft tissue curettage --
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

### Oral Soft Tissue surgery

- Gingivectomy ﯩﭗ
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- . Frenectomy
- Papillectomy
- Photocoagulation

### Cosmetic Dentistry

- Light activation for bleaching materials for teeth whitening
- Lasers-assisted bleaching/whitening of the teeth

Prescription Use: X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of Office of Device Evaluation (ODE)

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

**510(k) Number**

510(k) Submission Fotona XD Diode Laser System / v2