WAVELIGHT IDAS

K053604 · Wavelight Laser Technologie AG · GEX · Feb 22, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053604
• Device Name: WAVELIGHT IDAS
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The IDAS laser system is intended for use for Aesthetics: vascular lesions, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemanqiomas, port wine stains, rosacea.

Device Story

IDAS laser system is a 532 nm surgical laser for treating superficial vascular and pigmented lesions. Device emits 532 nm radiation, strongly absorbed by hemoglobin and melanin, penetrating 0.1-1 mm into skin to heat target structures. Operated by physicians in clinical settings. System offers continuous wave (cw) or pulsed operating modes. Beam transmission occurs via fiber and handpiece with adjustable adapters for spot size; bare fiber transmission also supported. Physician selects parameters including spot size, fluence/power, pulse duration, frequency, and aiming beam intensity to customize treatment. Device provides localized thermal effect to target lesions.

Clinical Evidence

No clinical data presented.

Technological Characteristics

532 nm wavelength laser; continuous wave (cw) and pulsed operating modes; fiber-optic beam delivery with handpiece and adjustable spot size adapters; bare fiber option; physician-controlled parameters (fluence, pulse duration, frequency).

Indications for Use

Indicated for patients requiring treatment of superficial vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g., café-au-lait stains, lentigo), hemangiomas, port wine stains, and rosacea.

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 faser system AURA (K951034)

Submission Summary (Full Text)

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

053604

Image /page/0/Picture/2 description: The image shows the word "WaveLight" with a symbol to the left of the word. The symbol is three horizontal lines that are curved to look like waves. There is a registered trademark symbol to the right of the word.

#### 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

WaveLight Laser Technologie, AG Submitter: Am Wolfsmantel 5 91058 Erlangen Germany Alexander Popp Contact Person: Am Wolfsmantel 5 91058 Erlangen Germany Telephone: [phone] Fax: [phone] November 14, 2005 Summary Preparation Date: 2. Names IDAS Device Name:

Classification Name:

Laser Instrument, Surgical Powered Product Code: GEX Panel: Dermatology and Plastic Surgery

#### 3. Predicate Devices

The IDAS laser system is substantially equivalent to the Laserscope faser system AURA (K951034).

## 4. Device Description

The IDAS laser system (532 nm) is used for the treatment of superficial vascular lesions and for pigmented lesions.

The laser radiation emitted by this type of faser system has a wavelength of 532 nm. Radiation of this wavelength is characterized by a particularly strong absorption by hemoglobin and melanin. The radiation emitted by the laser penetrates into the human skin 0.1 - 1 mm thus being able to locally heat up even deeper-lying target structures which consequently leads to the desired effect.

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

K053604

Image /page/1/Picture/1 description: The image shows the word "WaveLight" in a simple, sans-serif font. To the left of the word is a symbol that looks like three horizontal, curved lines stacked on top of each other. The symbol is reminiscent of a wave pattern, which complements the name "WaveLight."

#### 510(k) Summary of Safety and Effectiveness

The laser system (532 nm) can be used in two different operating modes: In the "cw" (= continuous wave) mode or in the "pulsed" operating mode.

Beam transmission is ensured by a fiber and a handpiece with different adapters which are used to adjust the spot diameter on the skin. Beam transmission, however, can be also effected via a bare fiber.

While the parameter wavelength is specified by the device, spot size, fluence or power, pulse duration, frequency and the intensity of the aiming beam can be selected by the treating physician for optimal adjustment to individual requirements.

#### 5. Indications for Use

The IDAS laser system is intended for use for Aesthetics:

vascular lesions, spider naevi, teleangiectasis, red superficial veins of the legs and face, piqmented lesions (e.g. café-au-lait stains, lentigo), hemanqiomas, port wine stains, rosacea.

- 6. Performance Data
None presented.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and three lines representing its tail feathers. The eagle is a symbol of the United States and represents the department's mission to protect the health of all Americans.

. .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

WaveLight Laser Technologie AG c/o Mr. Jeffrey D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Drive PO Box 13995 Research Triange Park, North Carolina 27709-3995

Re: K053604 Trade/Device Name: IDAS 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: February 2, 2006 Received: February 6, 2006

Dear Mr. Rongero:

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}------------------------------------------------

Page 2 - Mr. Rongero

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin maing of substantial equivalence of your device to a legally prematics notification: "The 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 If you ucate specific advice for Jour as 100 ) 276-0115. Also, please note the regulation entitled, Contact the Office of Comphalled at (21) = 1) = 1 Part 807.97). You may obtain Missualiding Uy Terefono to premantovilibilities under the Act from the Division of Small other general informational 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. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# S WaveLight

#### 510 (k) Indications for Use

Indications for Use

510(k) Number (if known): N/A IDAS Device Name:

Indications for Use:

KOS 3604

The IDAS laser system is intended for use for Aesthetics:

vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. café-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

Prescription Use _ Over-The-Counter Use N/A > AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of (indication for use only

el.mall

Division of General. Restorative. and Neurological Devices

510(k) Number_ko5 3604

0025