FOTONA TANDEM LASER SYSTEM

K022837 · Fotona D.D. · GEX · Nov 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022837
• Device Name: FOTONA TANDEM 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

Indications for Use

The Fotona Tandem Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-VI.

Device Story

Fotona Tandem Laser System utilizes Nd:YAG (1064 nm) and KTP (532 nm) laser technology for surgical and aesthetic applications. System features two optical cavities activated by flashlamps; red diode aiming beam reflected via beamsplitter. Physician selects wavelength via control panel; laser energy delivered through optical fiber to focusing handpieces in non-contact mode. Shared power supply, control, and cooling systems. Used by physicians in dermatology, general, and plastic surgery. Device enables selective photothermolysis of target chromophores (melanin for hair reduction; vascular targets for coagulation). Clinical benefits include stable long-term hair reduction and effective management of vascular lesions and soft tissue surgical needs.

Clinical Evidence

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

Technological Characteristics

Dual-wavelength laser system (1064 nm Nd:YAG and 532 nm KTP); flashlamp-pumped; non-contact delivery via optical fiber and handpieces; shared power supply, control, and cooling systems; internal computer-controlled wavelength selection.

Indications for Use

Indicated for patients requiring incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue (including skin, muscle, cartilage, organs, glands) and for permanent hair reduction in Fitzpatrick skin types I-VI.

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

• Fotona Dualis long pulse KTP laser system
• Fotona Dualis Nd:YAG laser system
• Palomar Clear Light Nd:YAG laser system (Palomar Q-YAG 5)

Submission Summary (Full Text)

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K 022837

I. General Information

#### Summary of Safety and Effectiveness Data Appendix E:

NOV 2 5 2002

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| Company : | Fotona d.d.<br>Stegne 7, 1210 Ljubljana<br>SLOVENIA |
|-----------------------|-----------------------------------------------------------------|
| Contact Person : | Mojca Valjavec |
| Preparation Date : | 08-08-02 |
| Device Trade Names : | Fotona Tandem Laser System |
| Common Name : | Combination of Long Pulse Nd:YAG and<br>Nd:YAG/KTP Lasers |
| Classification Name : | Instrument, Surgical, Powered, Laser<br>79-GEX<br>21 CFR 878-48 |

# II. Description

The Fotona Tandem laser system is based on the Nd: YAG (1064 nm) and KTP (532 nm) laser technology. There are two optical cavities containing the Nd:YAG and KTP crystals. Both are activated by means of the use of flashlamps. After each 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 through the optical fiber delivery systems to the focusing handpieces.

Both lasers are used in non-contact mode.

Both laser heads share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: Y AG head or the KTP (Inixedwavelength 1064/532 nm) head. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

# III. Intended Use

The Fotona Tandem Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-VI.

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# IV. Summary of Substantial Equivalence

Fotona believes that its Tandem laser system is substantially equivalent to the Fotona Dualis " long pulse KTP laser system previously cleared for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, to the Fotona Dualis' Nd:YAG laser system previously cleared also for permanent hair reduction in Fitzpatrick skin types I - VI, and to the Palomar Clear Light Nd:YAG laser system, marketed under Palomar Q-YAG 5. Similar as the Fotona Tandem, the Palomar system incorporates dual wavelengths (1064 and 1064/532 nm) and has been cleared for treatment of vascular lesions and removal of hair.

They therefore have the same Intended Use as the Fotona Tandem laser system.

The Tandem laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the Fotona Dualis " and the Fotona Dualis YP.

The risk and benefits for the Tandem 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 Tandem laser system.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract graphic consisting of three stylized human profiles facing to the right, stacked one above the other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2002

Fotona D. D Moica Valiavec OA/RA Manager Stegne 7, 1210 Ljubljana Slovenia

Re: K022837

Trade/Device Name: Fotona Tandem Laser System Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered, 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 (OS) 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 5100k) 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,

Muriam C. Provost

(Celia M. Witten, Ph.D., MD., MD.
Director 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

510(k) Number (if known): KO22837

Device Name:

Fotona Tandem Nd: YAG/KTP Laser System and Accessories

Indications For Use:

The Fotona Tandem Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent hair reduction in Fitzpatrick skin types I-V1.

### KTP Laser (532 + 1064 nm)

The Fotona Tandem KTP laser is intended for incision, vaporization, coaqulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology :

The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

### Nd:YAG Laser (1064 nm)

The Tandem 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 long-term stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ●
- For coaqulation 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) |
|------------------------------------------|-------------------------------------------------------------|
| | Miriam C. Provost |
| | (Division Sign-Off) |
| | Division of Gen. 1. Restorative<br>and Neurological Devices |
| Prescription Use<br>(Per 21 CFR 801.109) | 510(k) Number ^OR K022837 Over-The-Counter Use |