CANDELA SMOOTHBEAM LASER SYSTEM

K014128 · Candela Corp. · GEX · Oct 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014128
• Device Name: CANDELA SMOOTHBEAM LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smoothbeam Laser System is indicated for the treatment of back acne.

Device Story

Smoothbeam Laser System is a diode medical laser for dermatology; treats back acne. System includes power supply, optical delivery system, software control, and Dynamic Cooling Device (DCD). Laser energy delivered via optical fiber to handpiece, producing circular beams on skin. DCD provides cryogen spray bursts to cool skin, minimizing thermal damage and reducing pain. Operated by clinicians in a clinical setting; users select parameters via control panel. Safety interlocks protect patients and operators. Device output affects tissue to treat acne; clinical benefit is effective acne reduction.

Clinical Evidence

Clinical trials demonstrated the effectiveness of the Smoothbeam Laser System in the treatment of back acne.

Technological Characteristics

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

Indications for Use

Indicated for the treatment of back acne in patients requiring laser dermatological intervention.

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 1450 nm Diode Laser (K002421)

Submission Summary (Full Text)

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Image /page/0/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 black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.

K 014128

#### 510 (k) SUMMARY

# OCT 0 4 2002

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, and intended for use in the treatment of back acne.

| Submitted by: | Candela Corporation |
|---------------------|---------------------------------------------------------------------------------------------------------------------|
| Address: | 530 Boston Post Road<br>Wayland, MA 01778-1886 |
| Contact Person: | Lorraine Nelson<br>Manager, Regulatory Affairs |
| Date Prepared: | December 14, 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 Device: | Candela 1450 nm Diode Laser (K002421) |

Description of the Smoothbeam Laser System: The Diode laser is a diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of back acne. 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 multiple bursts 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 back acne.

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 back acne.

Summary of Substantial Equivalence: The Candela Smoothbeam Laser System with an additional indication for back acne, 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 of clinical data, Candela believes that its Smoothbeam Laser System is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 04 2002

ood and Drug Administration 200 Corporate Boulevard lockville MD 20850

Mr. William H. McGrail Vice President. Research and Development Candela Corporation 530 Boston Post Road Wayland, MA 01778-1886

Re: K014128 Trade/Device Name: Candela Corporation Smoothbeam 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: July 10, 2002 Received: July 15, 2002

Dear Mr. McGrail:

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 - Mr. William H. McGrail

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,

. Mark A. Willians

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/0 description: The image shows a logo with a stylized flame on the left and the word "CANDELA" on the right. The flame is divided into two sections, with the left side being solid black and the right side consisting of diagonal lines. The word "CANDELA" is written in a simple, sans-serif font, with each letter clearly spaced and defined.

### INDICATION FOR USE STATEMENT

510(k) Number (if known):

Candela Corporation Smoothbeam Laser System Device Name:

Indications For Use:

The Candela Smoothbeam Laser System is indicated for use for the treatment of back acne.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number. K014128

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