CANDELA CBEAM PULSED DYE LASER SYSTEM

K020958 · Candela Corp. · GEX · Jun 21, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020958
• Device Name: CANDELA CBEAM PULSED DYE LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Cbeam Pulse Dye Laser is indicated for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Periorbital wrinkles and the treatment of wrinkles. Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesion, such as warts.

Device Story

585 nm flash-lamp excited pulse dye laser; delivers energy via optical fiber to handpiece; produces circular beams (5, 7, 10 mm). Includes optional Dynamic Cooling Device (cryogen spray) for epidermal protection. Operated by physicians in clinical settings via onboard control panel. Safety interlocks protect patients/operators. Laser energy induces photocoagulation of vascular/cutaneous lesions; cryogen spray provides cooling prior to laser pulse. Output allows precise treatment of vascular/pigmented lesions and wrinkles; improves clinical outcomes by targeting specific chromophores while minimizing thermal damage to surrounding tissue.

Clinical Evidence

Bench testing only. Device conforms to Laser Performance Standard (21 CFR 1040), UL 2601 Electrical Safety Standard, and EN 60601-1-2.

Technological Characteristics

585 nm flash-lamp excited pulse dye laser. Energy delivered via optical fiber to 5, 7, or 10 mm handpiece. Includes integrated cryogen spray cooling system. Electrical safety per UL 2601 and EN 60601-1-2. Laser performance per 21 CFR 1040.

Indications for Use

Indicated for patients requiring treatment of benign cutaneous vascular lesions (telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte), benign cutaneous lesions (warts, scars, striea, psoriasis), and wrinkles (including periorbital). Applicable across general surgery, dermatology, plastic surgery, gynecology, and podiatry.

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

• Candela Clearbeam Pulse Dye Laser (K013043)
• SLS Biophile Ltd NLite (K013461)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black and white and has a modern design. The word "CANDELA" is in a simple, sans-serif font.

K020958

#### General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Cbeam Pulse Dye Laser System, which is substantially equivalent to previously marketed devices intended for photocoagulation of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles and wrinkles.

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine Nelson |
| Date prepared: | March 21, 2002 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use<br>in General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Cbeam Pulse Dye Laser System |
| Predicate Devices: | Candela Clearbeam Pulse Dye Laser (K013043), SLS Biophile<br>Ltd NLite (K013461) |

#### Description:

The Cbeam is a 585 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor, to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma. Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars. striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles. The Cbeam laser may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7 or 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure. is delivered via a hose to a nozzle located in the handpiece.

The Candela Cbeam Pulse Dye Laser is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

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Image /page/1/Picture/1 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is made up of a solid black shape on the left and a series of horizontal lines on the right. The word "CANDELA" is written in a simple, sans-serif font.

#### Testing:

As a laser product, the Cbeam Pulse Dye Laser is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the Cbeam conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by and required by the European Community.

#### Summary of Substantial Equivalence:

The Candela Cbeam Laser has the same intended use, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelength and / or the same maximum delivered power as the predicate devices.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that its Candela Cbeam Laser System is substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized image of three human profiles facing right, stacked on top of each other. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 1 2002

Ms. Lorraine Nelson Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

Re: K020958

Trade/Device Name: Candela Cbeam Pulsed Dye Dermatology Laser Regulation Number: 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 21, 2002 Received: March 25, 2002

Dear Ms. Nelson:

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 (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.

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Page 2 - Ms. Lorraine Nelson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Stipt Rhode

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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is made up of a solid black shape on the left and a series of horizontal lines on the right. The word "CANDELA" is written in a simple, sans-serif font.

# 510(k) Number (if known): __ KA20958

Device Name: Candela Cbeam Pulse Dye Laser System

Indications For Use:

The Candela Cbeam Pulse Dye Laser is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.

For treatment of benign cutaneous vascular lesion, such as facial Dermatology/Plastic Surgery: and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Periorbital wrinkles and the treatment of wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.

Podiatry: Treatment of benign cutaneous lesion, such as warts.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K020958 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
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