CANDELA SMOOTHBEAM LASER SYSTEM

K013825 · Candela Corp. · GEX · Feb 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013825
• Device Name: CANDELA SMOOTHBEAM LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles. The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment

Device Story

Smoothbeam Laser System is a continuous wave diode laser for dermatological applications. System components include power supply, optical delivery system, software control, and Dynamic Cooling Device (DCD). Laser energy is delivered via optical fiber to a handpiece, creating circular beams on skin. DCD delivers cryogen spray bursts to skin surface via handpiece nozzle to minimize thermal damage and reduce pain. Operated by clinicians in a clinical setting; users select parameters via control panel. Safety interlocks protect patients and operators. Device provides therapeutic benefit by treating periorbital wrinkles and performing soft tissue surgery with hemostasis.

Clinical Evidence

Clinical trials demonstrated the effectiveness of the Smoothbeam Laser System in the treatment of periorbital wrinkles.

Technological Characteristics

Continuous wave diode laser; 1450 nm wavelength. Includes Dynamic Cooling Device (cryogen spray). Safety interlock systems. Conforms to 21 CFR 1040 (Laser Performance Standard), UL 2601 (Electrical Safety), and EN 60601-1-2. Embedded processor control.

Indications for Use

Indicated for patients requiring dermatological soft tissue procedures (incision, excision, ablation, vaporization with hemostasis) or treatment of periorbital wrinkles.

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

• Laser Aesthetics CoolTouch (K003715)
• Candela 1450 nm Diode laser (K002421)

Submission Summary (Full Text)

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K013825

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ANDELA

General Information: This 510(k) is to provide notification of su

General Information: This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam Laser System, which is substantially equivalent to a previously marketed device intended for use in the treatment of periorbital wrinkles.

| Submitted by: | Candela Corporation |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| Address: | 530 Boston Post Road<br>Wayland, MA 01778-1886 |
| Contact Person: | Lorraine Nelson<br>Manager, Regulatory Affairs |
| Date Prepared: | November 16, 2001 |
| Device Trade Name: | Smoothbeam Laser System |
| Device Common Name: | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General<br>and Plastic Surgery and in Dermatology) |
| Predicate Devices: | Laser Aesthetics CoolTouch (K003715) and Candela 1450 nm Diode laser<br>(K002421) |

Description of the Smoothbeam Laser System: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam 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 beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen 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 Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.

Intended use of Smoothbeam Laser System: The Smoothbeam Laser System is indicated for the treatment of periorbital wrinkles.

Performance Standards: As a laser product, the Smoothbeam Laser System is required to conform and does conform to the Laser Performance Standard (21 CFR 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 the European Community.

Clinical Performance Data: Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles.

Summary of Substantial Equivalence: The Candela Smoothbeam Laser System has the same intended use, utilizes similar operating principles and matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Smoothbeam Laser System is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Ms. Lorraine Nelson Manger, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778

Re: K013825

Trade/Device Name: Candela Smoothbeam 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: Class II Product Code: GEX Dated: November 16, 2001 Received: November 19, 2001

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

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Page 2 - Ms. Lorraine Nelson

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.

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

to" 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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## INDICATION FOR USE STATEMENT

510(k) Number (if known): K013825

Candela Corporation Smoothbeam Laser System Device Name: Indications For Use:

The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.

The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Muriam C. Provost

Division of General, Resto ative and Neurological Devices

CANDELA CORPORATIO 530 Boston Post Road, Month Not 508-358-7637 Fax: [phone]