CANDELA SMOOTHBEAM LASER SYSTEM

K030834 · Candela Corp. · GEX · Dec 3, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030834
• Device Name: CANDELA SMOOTHBEAM LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 3, 2003
• 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 the treatment of mild to moderate inflammatory acne vulgaris. 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

The Candela Smoothbeam Laser System is a continuous wave diode laser used for treating mild to moderate inflammatory acne vulgaris. The system includes a laser delivery system, software control, and a Dynamic Cooling Device (DCD). Laser energy is delivered via an optical fiber to a handpiece, producing circular beams on the skin. The DCD delivers a cryogen spray to the skin through a nozzle in the handpiece to cool the skin and reduce pain during treatment. The device is operated by clinicians in a professional setting. Users regulate operation via a control panel. Safety interlocks are integrated to protect patients and operators. The device benefits patients by providing a non-invasive treatment for inflammatory acne.

Clinical Evidence

A controlled clinical study using a previously cleared device demonstrated the safety and effectiveness of the Smoothbeam Laser System for the treatment of mild to moderate inflammatory acne vulgaris.

Technological Characteristics

Continuous wave diode laser; 1450 nm wavelength; includes Dynamic Cooling Device (cryogen spray); optical fiber delivery; embedded processor control; safety interlock systems; conforms to 21 CFR 1040 (Laser Performance Standard), UL 2601 (Electrical Safety), and EN 60601-1-2.

Indications for Use

Indicated for patients with mild to moderate inflammatory acne vulgaris.

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 Smoothbeam 1450 nm Diode Laser System (K022884)

Submission Summary (Full Text)

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K030834 1/1

### 510(k) SUMMARY

#### General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam Laser System, This 110(x) is to provide not of enously marketed device and intended for use in the treatment of mild to moderate inflammatory acne vulgaris.

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lorraine Calzetta Patrovic |
| Date prepared: | March 7, 2003 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in Gencral<br>and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Smoothbeam Laser System |
| Predicate Devices: | Candela Smoothbeam 1450 nm Diode Laser System (K022884) |

#### Description:

The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used I he Dood laser is a Condinous Ware, the Candela Smoothbeam Laser System Laser System Ti for use in delivery system, software control system and Dynamic Cooling Device. The laster on the cliently. The Daser on energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic ellergy is delivered via an option to a simeen spray during the lascr treatment. The cryogen is delivered via a hose to a nozzle located in the hands of by get ipanic Cooling Device functions to cool the skin during the a 105€ to a nozzio nodator ar the mail daring 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.

#### Testing:

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 I crommiss on with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community.

#### Safety and Effectiveness Information:

A controlled clinical study, using a device that has been cleared for use in the market, produced results that A couronea chat the Smoothbeam Laser System is safe and effective for the treatment of mild to moderate inflammatory acne vulgaris ..

## Summary of Substantial Equivalence:

The Candela Smoothbeam Laser System described in this submission is identical to the currently markcted Candela Smoothbeam Laser System based on operating principles, materials, mechanism of action, design, Candela Ginobulan Last Of Clark Candela; believes that the Smoothbeam Lascr is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

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

Re: K030834 K020054
Trade/Device Name: Candela Corporation 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: II Product Code: GEX Dated: November 17, 2003 Received: November 21, 2003

Dear Ms. Patrovic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocuritied the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for disc stated in the encrosure) to regally manager in the Medical Device Amendments, or to commerce prof to May 20, 1978, in eacordance with the provisions of the Federal Food, DNIg, devices mail have occh reculise in above approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require approvisions of the general controls provisions of the Act. The 1 ou may, mercrore, manel as act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sce above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 world). Existing major regulations affecting your device can may be subject to basi lassillations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oceaning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Hao made a and regulations administered by other Federal agencies. You must of any i coloral statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct CI K I att 6077, adomig (21 OFREE and (21 CFR Part 820); and if applicable, the clectronic forth in the quality bysteins (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 leter will acation. The FDA finding of substantial equivalence of your device to a legally promatice noticate 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 other general international and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Cclia 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 STATEMENT

Ko30834 510(k) Number (if known):

Device Name: Candela Corporation Smoothbeam Laser System

Indications For Use:

The Candela Smoothbeam Laser System is indicated for the treatment of mild to moderate inflammatory acne vulgaris.

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

(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_

Miriam C. Provost

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

510(k) Number K030834