CANDELA FAMILY OF PULSE DYE LASER SYSTEMS

K050673 · Candela Corp. · GEX · Jun 13, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050673
• Device Name: CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, 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 Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris. Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Story

Candela Family of Pulsed Dye Laser Systems are 585/595nm flash-lamp excited pulse dye lasers. Device delivers laser energy via optical fiber to handpiece; produces circular beams (3, 7, 10, 12, or 3x10 mm diameters) on skin. Operated by clinicians in clinical settings via onboard control panel. Safety interlock systems protect patients/operators. Output energy photocoagulates vascular lesions and treats various cutaneous conditions. Clinical benefit includes non-invasive treatment of vascular/pigmented lesions, acne, and skin resurfacing.

Clinical Evidence

Bench testing only. Device conforms to CDRH Laser Standard (21 CFR 1040) and UL/IEC 60601-1 Electrical Safety Standard.

Technological Characteristics

Flash-lamp excited pulsed dye laser; 585nm and 595nm wavelengths. Energy delivered via optical fiber to handpiece. Beam diameters: 3, 7, 10, 12, or 3x10 mm. Safety interlock systems. Conforms to UL/IEC 60601-1 and 21 CFR 1040.

Indications for Use

Indicated for patients requiring treatment of benign cutaneous vascular lesions (e.g., telangiectasia, port wine stains, hemangiomas, angioma, Poikiloderma of Civatte), benign cutaneous lesions (e.g., warts, scars, striae, psoriasis), wrinkles, benign epidermal pigmented lesions, and inflammatory acne vulgaris. 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 Family of Pulsed Dye Lasers (K043251)
• Cynosure VStar (Tristar PDL) (K033176)
• Cynosure VStar (Tristar PDL) (K032565)

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 made up of a solid black shape on the left and a series of horizontal lines on the right.

JUN 1 3 2005

### 510(k) Summary

## General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Family of Pulsed Dye Lasers which is substantially equivalent to previously marketed devices indicted for the following uses:

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

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, 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 Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris

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

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

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine Calzetta |
| Date prepared: | March 11, 2005 |
| 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, Candela Family of Pulse Dye Laser Systems<br>Predicate Devices:<br>Candela Family of Pulsed Dye Lasers - K043251<br>Cynosure VStar (Tristar PDL) - K033176, K032565 |

#### Description:

The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses:

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

13 p. 1052

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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 black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.

#### Summary cont.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as Dormatorogy I hanto Baasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civate, and benign cutaneous lesions, such as warts, scars, atriae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented lesions. Treatment of Inflammatory Acne Vulgaris I regilented learning - Treation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 3, 7 or 10, 12 or 3x10 millimeters on the skin..

The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to The Canationts and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

#### Testing:

As a laser product, the Candela Family of Pulsed Dye Laser Systems conforms to the CDRH I is a laser produce Standard (21 CFR 1040). In addition the laser conforms to UL/IEC 60601-1. Electrical Safety Standard.

#### Summary of Substantial Equivalence:

The Candela Family of Pulsed Dye Laser Systems, has the same intended use, utilizes similar operating principles and matches key design aspects, 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 Family of Pulsed Dye Laser Systems is 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2005

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

Re: K050673

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: March 11, 2005 Received: March 15, 2005

Dear Ms. Calzetta:

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.

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Page 2 - Ms. Lorraine Calzetta

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]. 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 Manufacturers, International 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,

Ech

Miriam C. Provost, Ph.D. Acting 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): KO50673

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 :

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

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial Demilatologyn lastic Ourgery. Or treatine, hemangiomas, angioma, spider angioma, and leg telangicolasia, rosaooa, port utaneous lesions, such as warts, scars, striae and Politionermia of Orvate, and bonigh Saturest of Benign Epidermal Pigmented Lesions.

Treatment of Inflammatory Acne Vulgaris

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

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

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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