FOTONA DUALIS PLUS ND:YAG LASER SYSTEM

K022839 · Fotona D.D. · GEX · Nov 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022839
• Device Name: FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
• Applicant: Fotona D.D.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona DUALIS Plus Nd: YAG laser system 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

Flashlamp-pumped Nd:YAG laser system; generates 1064 nm wavelength light. Input: electrical energy to flashlamps; Output: pulsed laser beam. Delivery: optical fiber to focusing handpiece; non-contact mode. Aiming: red diode laser. Operation: microprocessor-controlled; internal closed-loop water-air heat exchanger for thermal regulation. Used in clinical settings (dermatology, plastic/general surgery) by trained professionals. Laser energy targets chromophores (melanin, hemoglobin) in soft tissue via selective photothermolysis; enables hair reduction, coagulation, hemostasis, and tissue ablation. Microprocessor manages parameter selection and safety monitoring.

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 diode aiming beam.

Indications for Use

Indicated for patients of Fitzpatrick skin types I-VI requiring soft tissue surgical/aesthetic procedures, including hair reduction, vascular lesion coagulation/hemostasis, and general/plastic surgery soft tissue incision, excision, dissection, or ablation.

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

• Altus Medical Aesthetic Nd:YAG Laser

Submission Summary (Full Text)

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# 839 Appendix E:

#### 1/2 Summary of Safety and Effectiveness Data

I. General Information

NOV 2 5 2002

| Company : | Fotona d.d.<br>Stegne 7, 1210 Ljubljana<br>SLOVENIA |
|-----------------------|-----------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 08-05-01 |
| Device Trade Names : | Fotona DUALISXP Plus Nd:YAG Laser Systern |
| 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 Fotona DUALIS 8 Plus system is based on the Nd: Y AG laser technology. Within the system, an optical cavity contains the Nd: Y AG 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 beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.

## II. Intended Use

The Fotona DUALIS* Plus Nd: YAG laser system 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 system 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 Fotona DUALIS'x Plus laser shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Altus Medical Aesthetic Nd:YAG Laser.

510(k) Submission: The Fotona DUALISNº Plus Nd:YAG Laser System

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K022839 2/2 Technologically, the predicate device has similar characteristics to the DUALISM Plus laser. Both 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.

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

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

Both 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*P Plus laser system are comparable to the predicate device 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* Plus laser system.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

#### Public Health Service

Food and Drug Administration 200 Corporate Boulevard ockville MD 20850

NOV 2 5 2002

Fotona D. D. Mojca Valjavec OA/RA Manager . Stegne7, 1210 Ljubljana Slovenia

Re: K022839

Trade/Device Name: Fotona DUALIS Plus Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Instrument, powered surgical laser Regulatory Class: Class II Product Code: GEX Dated: August 20, 2002 Received: August 27, 2002

Dear Sir or Madam:

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

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Page 2 - Sir or Madam

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 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). 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,

Miriam C Provost

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

Enclosure

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# APPENDIX

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K (222 3 9

Device Name:

Fotona DUALISNY Plus Nd: YAG Laser System and Accessories

Indications For Use:

The Fotona DUALIS'" Plus Nd: YAG laser system 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

iriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number: KC22839

510(k) Submission: The Fotona DUALISM Plus Nd:YAG Laser System