FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM

K024204 · Fotona D.D. · GEX · Jul 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024204
• Device Name: FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
• Applicant: Fotona D.D.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for incision, excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Device Story

Fotona Fidelis Plus Nd:YAG laser system is a microprocessor-controlled surgical laser accessory designed for integration with the Fotona Fidelis Er:YAG laser system. The device generates 1064 nm pulsed laser light, delivered to intraoral soft tissue via an optical fiber and handpiece. The system is operated by clinicians in a dental or clinical setting, utilizing the host system's touchscreen interface for activation. The laser energy is used for incision, excision, and coagulation of soft tissues, including gingival procedures and periodontal debridement. By providing precise tissue interaction, the device facilitates surgical procedures, promotes hemostasis, and aids in the management of diseased or inflamed oral tissues, potentially improving clinical indices such as probe depth and gingival bleeding.

Clinical Evidence

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

Technological Characteristics

Flashlamp-pumped Nd:YAG laser; 1064 nm wavelength; microprocessor-controlled; optical fiber delivery system; integrated with host Fidelis Er:YAG laser system; touchscreen interface.

Indications for Use

Indicated for intraoral soft tissue procedures including biopsies, frenectomy, gingivectomy, gingivoplasty, implant recovery, abscess drainage, LAUP, leukoplakia, operculectomy, pulpotomy, reduction of hyperplasia/hypertrophy, removal of filling materials, soft tissue crown lengthening, sulcular debridement, tissue retraction, apthous ulcer treatment, and vestibuloplasty.

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

• Sunlase 800P Nd:YAG laser system

Submission Summary (Full Text)

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#### K024204 1/2

# Appendix E : Summary of Safety and Effectiveness Data

### I. General Information

JUL 0 7 2003

| Company : | Fotona d.d.<br>Stegne 7, 1210 Ljubljana<br>SLOVENIA |
|-----------------------|-----------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 12-10-02 |
| Device Trade Names : | Fotona Fidelis Plus Nd: YAG Laser System |
| Common Name : | Nd: YAG Laser |
| Classification Name : | Instrument, Surgical, Powered, Laser<br>79-GEX<br>21 CFR 878-48 |

## II. Description

The Fotona Fidelis Plus Nd:YAG system is a microprocessor controlled device which generates laser light with a wavelength of 1064 nm when used in conjunction with a host Fidelis Er: YAG system. When combined, the Nd: YAG (1064 nm) accessory and the host Er: Y AG system constitute the Fidelis Plus laser system.

The Fotona Fidelis Plus Nd:YAG system is designed as an accessory for use with the Fotona Fidelis Er:YAG laser system. The Nd:YAG (1064 nm) sub-system is functionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 1064 nm pulsed light via the same touchscreen as the host Er: Y AG.

The Fidelis Plus Nd:YAG laser system consists of 3 major sub-systems:

a) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and a handpiece.

b) An electronic power supply and interface circuitry.

c) An optical chamber containing laser rod and laser cavity optics.

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### III. Intended Use

K024204 2/2

The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for incision, excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

### IV. Summary of Substantial Equivalence

Fotona believes that its Fidelis Plus Nd:YAG laser system is substantially equivalent to the Sunlase 800P Nd:YAG laser system previously cleared for incision, excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. It therefore has the same Intended Use as the Fotona Fidelis Plus Nd: YAG laser system..

Technologically, the predicate device has similar characteristics to the Fotona Fidelis Plus Nd: YAG, both comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fiber delivery system and exits the proximal tip of the fiber.

The risk and benefits for the Fotona Fidelis Plus Nd: Y AG laser system are comparable to the predicate devices when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Fotona Fidelis Plus Nd: YAG laser system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matjaz Lukac President Fotona d.d. Stegne 7. 1210 Ljubjana, Slovenia

'JUL 0 7 2003

Re: K024204

Trade/Device Name: Fotona Fidelis Plus Nd: YAG Laser System and Accessories 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: March 28, 2003 Received: April 9, 2003

Dear Mr. Lukac:

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. Iisting 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.

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Page 2 - Mr. Matjaz Lukac

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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.

Meriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Appendix F : Indications for Use Statement

K024204

510(k) Number (if known):

Device Name:

Fotona Fidelis Plus Nd: YAG Laser System and Accessories

Indications For Use:

The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for incision, excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

· Excisional and incisional biopsies

- · Excision and vaporization of herpex simplex I and II
- · Exposure of unerupted teeth

•Fibroma removal

- ·Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- •Hemostasis
- · Implant recovery ·
- · Incision and drainage of abscess
- · Laser assisted uvulopaletoplasty (LAUP)
- ·Leukoplakia
- · Operculectomy
- · Oral papillectomies
- •Pulpotomy and pulpotomy as an adjunct to root canal therapy
- ·Reduction of denture hyperplasia
- ·Reduction of gingival hypertrophy
- •Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- ·Removal of post-surgical granulations
- · Soft tissue crown lengthening
- · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- · Tissue retraction for impression
- · Treatment of apthous ulcers

·Vestibuloplasty

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

stem and Accessories