CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

K013748 · Candela Corp. · GEX · Feb 11, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013748
• Device Name: CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in: 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. Treatment of periocular wrinkles. Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Story

Vbeam Pulse Dye Laser is a 595 nm flash lamp-excited pulsed dye laser; uses embedded microprocessor for control. System includes power supply, optical delivery system, handpiece, and Dynamic Cooling Device (DCD). DCD delivers cryogen spray to skin surface to minimize thermal damage and reduce pain. Physician operates device via onboard control panel; laser energy delivered through optical fiber to skin. Safety interlock system protects patients and operators. Used in clinical settings for dermatological, surgical, gynecological, and podiatric procedures. Output affects clinical decision-making by enabling targeted photocoagulation of vascular and cutaneous lesions.

Clinical Evidence

Bench testing only. Device conforms to Laser Performance Standards (21 CFR 1000-1040), UL 2601 Electrical Safety Standard, and EN 60601-1-2.

Technological Characteristics

595 nm flash lamp-excited pulsed dye laser. Includes Dynamic Cooling Device (cryogen spray). Dimensions/form factor: laser enclosure with handpiece and hose. Connectivity: standalone with onboard control panel. Software: embedded microprocessor control. Sterilization: N/A (external use). Energy source: electrical power supply.

Indications for Use

Indicated for patients requiring photocoagulation of benign cutaneous vascular lesions (e.g., telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte) and benign cutaneous lesions (e.g., warts, scars, striae, psoriasis), and treatment of periocular wrinkles. Applicable to 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 System (K013043)
• Candela SPTL-1e Pulse Dye Laser (K011092)
• Candela Long Pulsed Dye Laser (K993671)
• Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292, K954934)
• SLS Biophile Ltd. NLite Pulse Dye Laser (K000811)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Candela logo and the date FEB 11 2002. The Candela logo is a stylized image of a flame. The text "CANDELA" is written in all caps below the logo. The date is written in a simple, sans-serif font.

# 510(k) Summary

## General Information:

Ocuchar Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Vbeam Pulse Dye I ms > Pro vio to provide is substantially equivalent to previously marketed devices intended for the photocoagulation of benign cutaneous lesions, such as warts, scars, striea and psoriasis; benign photocoughanon of oting, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte and in gynecology and treatment of periocular wrinkles.

| 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, Vbeam Pulse Dye Laser System |
| Predicate Devices: | Candela Clearbeam Pulse Dye Laser System (K013043) |
| | Candela SPTL-1e Pulse Dye Laser (K011092) |
| | Candela Long Pulsed Dye Laser (K993671) |
| | Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292,<br>K954934) |
| | SLS Biophile Ltd. NLite Pulse Dye Laser (K000811) |

#### Description:

The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded microprocessor. The Vbeam Pulse Dye Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular or elliptical laser beams onto the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.

The Candela Vbeam Pulse Dye Laser is equipped with a safety interlock system 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 Vbeam Pulse Dye Laser is required to conform and will conform to the Laser Performance Standards (21 CFR 1000 - 1040). In addition, the device will conform 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 (EC).

### Summary of Substantial Equivalence:

The Candela Vbeam Pulse Dye Laser System has the same intended use, utilizes similar operating principles and matches key design aspects, including spot sizes, pulse durations, wavelength and the same maximum delivered energy as the predicate devices.

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. L. Nelson Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

Re: K013748

Ro15746
Trade/Device Name: Candela Vbeam Pulse Dye Laser System 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: November 12, 2001 Received: November 13, 2001

Dear Mr. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to tegains and ment date of the Medical Device American be of the depend commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). alla Cosmette 71ct (71ct) that as not of corporal controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provisioning 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 elassined (600 a00 otrols. 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 r loase of acrised a determination that your device complies with other requirements of the Act that I Dr Has Internand regulations administered by other Federal agencies. You must or any I odolar statutes and regionements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF It Furt 6077, adoling (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 - Mr. L. 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 promated 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,

Miriam C. Provost

for 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/3/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 partially filled with horizontal lines, and the word "CANDELA" is in a simple, sans-serif font.

510(k) Number (if known): _ | _ 013748

Device Name: Candela Vbeam Pulse Dye Laser System

Indications For Use:

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

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

For treatment of benign cutaneous vascular lesions, 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, striae, and psoriasis. Treatment of periocular wrinkles.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musiam C. Provost

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

Prescription Use
(Per 21 CFR 801.109)

510(k) Number K013748

(Optional format 1-2-96)

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