CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B

K043251 · Candela Corp. · GEX · Feb 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043251
• Device Name: CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Family of Pulse Dye Laser Systems 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, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts. New Indication: Treatment of Benign Epidermal Pigmented Lesions

Device Story

Flash-lamp excited pulsed dye laser system; delivers laser energy via optical fiber to handpiece. Includes Dynamic Cooling Device (DCD) delivering cryogen spray to skin surface prior to laser pulse. Operated by clinicians in clinical settings via onboard control panel. Safety interlocks protect patients/operators. Used for photocoagulation of vascular/pigmented lesions and treatment of dermatological conditions. Output energy targets specific tissue chromophores; cryogen spray provides epidermal protection. Benefits include precise lesion treatment with reduced thermal damage to surrounding tissue.

Clinical Evidence

Bench testing only. Device conforms to Laser Performance Standard (21 CFR 1040) and Harmonized Standard EN 60601 1-2.

Technological Characteristics

Flash-lamp excited pulsed dye laser; embedded microprocessor control; optical fiber delivery; Dynamic Cooling Device (cryogen spray); safety interlocks; onboard control panel. Conforms to 21 CFR 1040 and EN 60601 1-2.

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, striae, psoriasis, benign epidermal pigmented lesions), wrinkles, and inflammatory acne vulgaris. Used in 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 SPTL 1B Laser
• Candela Cbeam Pulsed Dye Laser
• Candela Vbeam Pulsed Dye Laser
• Cynosure Apogee
• Laserscope Aura KTP Laser
• GentelLA SE Family of laser Systems

Submission Summary (Full Text)

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FEB - 9 2005

#### 510(k) Summary

## General Information:

The purpose of this premarket notification application is to provide notification of substantial equivalence of the Candela Family of Family of Pulsed Dye Laser Systems, which are substantially equivalent to previously marketed devices intended for the following indications 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 Donnatoregor raine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

## New Indication: Treatment of Benign Epidermal Pigmented Lesions

There have been no modifications in design of the Lasers in the Pulsed Dye Family of Laser Systems which were previously cleared under K001093, K021180, K033331 and K033461.

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine Calzetta |
| Date prepared: | November 12, 2004 |
| 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, Family of Pulsed Dye Laser Systems |

Predicate Devices

| Candela<br>SPTL<br>1B<br>Laser | Candela<br>Cbeam<br>Pulsed<br>Dye<br>Laser<br>(aka | Candela<br>Vbeam<br>Pulsed<br>Dye<br>Laser | Cynosure<br>e Apogee | Laserscope Aura<br>KTP<br>Laser | GentelLA<br>SE<br>Family of<br>laser<br>Systems |
|--------------------------------|----------------------------------------------------|--------------------------------------------|----------------------|---------------------------------|-------------------------------------------------|
|--------------------------------|----------------------------------------------------|--------------------------------------------|----------------------|---------------------------------|-------------------------------------------------|

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Candela Family of Pulsed Dye Laser Systems 510k Summary

| | Clearbeam | | | | |
|---------|-----------|--------|---------|---------|---------|
| | am) | | | | |
| K001093 | K02118 | K03346 | K031488 | K984424 | K024371 |
| | 0 | 1 | | K024206 | |
| | K03333 | | | | |
| | 1 | | | | |

## Description:

The Candela Family of Pulse Dye Laser Systems are flash-lamp excited pulsed dye medical lasers, controlled by an embedded microprocessor., to be used 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 and leg Dermatology/Plastic Surgery: telangiectasia, rosacea, port wine stains, hemangiomas, angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles. Treatment of Inflammatory Acne Vulgaris

Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

## New Indication: Treatment of Benign Epidermal Pigmented Lesions

The Lasers 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 hand piece. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the hand piece . The Candela Family of Pulsed Dye Laser Systems are 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.

## Testing:

As a laser product, the Family of Pulsed Dye Laser Systems are required to conform and do conform to the Laser Performance Standard (21 CFR 1040). In addition the lasers conform to the Harmonized Standard EN 60601 1-2, Part 2 established by and required by the European Community.

#### Summary of Substantial Equivalence:

The Candela Family of Pulsed Dye Laser Systems is equivalent in key design aspects, functional features and indications for use as the predicate devices for the treatment of epidermal pigmented lesions.

On the basis of similarities in functional features, method of operation, and intended uses, Candela Corporation believes that the Candela Family of Pulsed Dye Laser Systems are substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, representing the department's focus on people and their well-being.

Public Health Service

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043251

Trade/Device Name: Candela Family of Pulsed Dye Laser Systems 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: November 12, 2004 Received: November 23, 2004

Dear Ms. Patrovic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease of the enactment date of the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been revat do not require approval of a premarket approval application (PMA). and Cosmetic (11ct) the market the device, subject to the general controls provisions of the Act. The r ou may, arerely missis of the Act include requirements for annual registration, listing of general controll proving 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 If your device is elabilition (sontrols. Existing major regulations affecting your device can may be subject to basil additions, 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 1 loase be advised that i Drivisation of our device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must of any I outer states and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K ratt 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lorraine Calzetta Patrovic

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yours ough finding of substantial equivalence of your device to a legally prematics notification. Thesults 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 rr you attire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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 A. Wilkerson

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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# Indications for Use

510(k) Number (if known):

Device Name: Candela Family of Pulsed Dye Laser Systems

Indications For Use:

The Candela Family of Pulse Dye Laser Systems 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, striae and psoriasis. and the treatment of wrinkles.

Treatment of Inflammatory Acne Vulgaris

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

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

## New Indication: Treatment of Benign Epidermal Pigmented Lesions

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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