CANDELA SMOOTHBEAM LASER SYSTEM

K022884 · Candela Corp. · GEX · Jan 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K022884
• Device Name: CANDELA SMOOTHBEAM LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 22, 2003
• 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 Atrophic Acne Scars.

Device Story

The Smoothbeam Laser System is a dermatology laser used by clinicians to treat atrophic acne scars. The system consists of a console with control electronics and software, a control/display panel, a fiberoptic-coupled handpiece, and an integrated skin cooling device that delivers cryogen via a hose to a nozzle in the handpiece. A safety interlock system is included. The device operates by delivering laser energy to the skin while simultaneously cooling the surface to protect the epidermis. The clinician uses the handpiece to target the treatment area, guided by the system's control interface. The output is intended to improve the appearance of atrophic acne scars, providing a therapeutic benefit to the patient.

Clinical Evidence

A clinical study was conducted to evaluate the effectiveness of the Smoothbeam Laser System for the treatment of atrophic acne scars. The study results indicated that the system is effective for this indication. No new safety issues were identified during the study.

Technological Characteristics

The system is a dermatology laser featuring a fiberoptic-coupled handpiece, integrated cryogen-based skin cooling system, and a safety interlock. It utilizes a laser system console with control electronics and software. Technical specifications such as wavelength and power are consistent with the predicate device.

Indications for Use

Indicated for the treatment of atrophic acne scars in patients requiring dermatological laser 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 Smoothbeam Laser (K013825)

Submission Summary (Full Text)

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KO 22884 1/2

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JAN 2 2 2003

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510 (k) Summary of Safety and Effectiveness for the Candela Smoothbeam Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510 (k) summary.

## I. General Information

| Applicant: | Candela Corporation |
|-----------------------|------------------------------------------------|
| Address: | 530 Boston Post Road<br>Wayland, MA 01778-1886 |
| Contact Person: | Lorraine Nelson<br>Manager, Regulatory Affairs |
| Date Prepared: | August 14, 2002 |
| II. Name | |
| Device Trade Name: | Smoothbeam Laser System |
| Device Common Name: | Dermatology Laser |
| Classification: | Class II<br>Product Code- GEX |
| III. Predicate Device | Candela Smoothbeam Laser (K0138257) |

#### IV. Product Description

The Smoothbeam Laser is comprised of the following main components:

- a laser system console (including software and control electronics) ●
- a control and display panel
- a fiberoptic-coupled handpiece
- a skin cooling device integrated into the laser (cryogen is delivered ● via a hose to a nozzle in the handpiece)
- a safety interlock system

#### V. Intended Use

The Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.

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# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

### VI. Rationale For Substantial Equivalence

The Candela Smoothbeam Laser System 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, and therefore is substantially equivalent to the currently marketed Candela Smoothbeam Laser System (K013825).

### VII. Safety and Effectiveness Data

A clinical study was performed that produced results that indicate that the Smoothbeam Laser System is effective for the treatment of Atrophic Acne Scars. No new safety issues were raised in the study of the Smoothbeam Laser.

### VIII. Conclusion

The Smoothbeam Laser is effective for the treatment of Atrophic Acne Scars.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2003

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

Re: K022884

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 11, 2002 Received: November 12, 2002

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 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 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 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]. 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) you may obtain. 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

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): KO2Z JPY 4

Device Name:

Candela Corporation Smoothbeam Laser System

Indications For Use:

The Candela Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.

(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

Muriam C. Provost

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

K022884

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