FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM

K013047 · Mojca Valijavec · GEX · Dec 6, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013047
• Device Name: FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
• Applicant: Mojca Valijavec
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology: - To effect stable long-term, or permanent, hair reduction in skin types I VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen. - For removal of unwanted hair. - For coagulation and hemostasis of vascular lesions. - For incision/excision of soft body tissue in dermatology . - For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation

Device Story

Fotona DUALIS Nd:YAG laser system; flashlamp-pumped Nd:YAG crystal generates 1064 nm wavelength light. System includes red diode aiming beam, beamsplitter, optical fiber delivery, and focusing handpiece. Operated by clinicians in general surgery, plastic surgery, and dermatology settings. Device functions in non-contact mode for selective photothermolysis of soft tissue chromophores. Microprocessor controls operation, parameter selection, and safety. Internal closed-loop water-air heat exchanger manages thermal output. Clinician uses system to perform tissue incision, excision, ablation, coagulation, and hair reduction. Benefits include precise tissue interaction and stable long-term hair reduction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flashlamp-pumped Nd:YAG laser; 1064 nm wavelength; optical fiber delivery; focusing handpiece; microprocessor-controlled; internal closed-loop water-air heat exchanger; Class I aiming beam.

Indications for Use

Indicated for patients of Fitzpatrick skin types I-VI requiring soft tissue surgery, dermatology procedures, or hair reduction. Applications include coagulation/hemostasis of vascular lesions, incision/excision/ablation of soft tissue, and permanent hair reduction via melanin targeting.

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

• Laserscope Lyra (K010834)
• Altus Medical Aesthetic Nd: YAG Laser (K003202)

Submission Summary (Full Text)

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#### DEC 0 6 2001 ppendix E:

# Summary of Safety and Effectiveness Data

- I. General Information
K013047

| Company : | Fotona d.d.<br>Stegne 7, 1210 Ljubljana<br>SLOVENIA |
|-----------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 05-09-01 |
| Device Trade Names : | Fotona DualisXP Nd:YAG Laser System<br>Fotona DualisVP Nd:YAG Laser System<br>Fotona Twinlight Nd:YAG Laser System |
| Common Name : | Nd:YAG Pulsed Surgical Laser System |
| Classification Name : | Instrument, Surgical, Powered, Laser<br>79-GEX<br>21 CFR 878-48 |

#### II. Description

The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.

## II. Intended Use

The family of Fotona DUALIS Nd: YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long-term stable reduction in number of hairs regrowing after a treatment regimen).

## III. Summary of Substantial Equivalence

The family of Fotona DUALIS lasers shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Laserscope Lyra (K010834) and to Altus Medical Aesthetic Nd: YAG Laser (K003202).

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Technologically, the predicate devices have similar characteristics to the DUALIS lasers. All systems 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 focusing handpiece.

All lasers utilize class I aiming beams which pose no hazard to the user.

All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence.

All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity.

The risk and benefits for the DUALIS family 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 DUALIS family.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo is simple and conveys a sense of national authority and health-related services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Mojca Valjavec, Dipl. Eng. Laser Division Fotona d.d. Stegne 7 1210 Ljubljana Slovenia

Re: K013047

Trade Name: Fotona DUALIS Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 6, 2001 Received: September 10, 2001

Dear Ms. Valjavec:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, and charter 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, (Trefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer and act include requirements for annual registration, listing of devices, Controls provisions or are ice, 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 If your device 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 or any 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 – Ms. Mojca Valjavec

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours over finding of substantial equivalence of your device to a legally premarket notifications of 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 and 11 you desire specific advise for in vitro diagnostic devices), please contact the Office of additionally 21 Cl 1 1 1 1 1 1 1 4 659. Additionally, for questions on the promotion and advertising of Compination at (301) 69 to the Office of Compliance at [phone]. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mistmational 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,

Susan Walker

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

Page I of 1

## INDICATIONS FOR USE STATEMENT

KO13047 510(k) Number (if known):

Device Name:

Family of Fotona DUALIS Nd:YAG Laser Systems and Accessories

Indications For Use:

The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:

- To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ◆
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology .
- For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Susan Walker, m

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

510(k) Number_KO13047

510(k) Submission: Family of Fotona DUALIS Nd: YAG Lasers