CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS

K063073 · Candela Corp. · GEX · Dec 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063073
• Device Name: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in the following uses: Pigmented Lesions Tattoos

Device Story

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) is a laser surgical system utilizing an Alexandrite rod, Q-switching mechanism, and xenon flashlamps to deliver 755 nm laser energy. The system includes a power supply, deionized water circulator for head cooling, and a microprocessor-based controller. Energy is delivered via a lens-coupled, user-replaceable optical fiber and handpiece. Operators (clinicians) select fluence and repetition rates via a control panel and display. The device supports 2mm, 3mm, and 4mm spot sizes. A calibration port with an internal meter verifies optical fiber transmission and handpiece output. The system is used in clinical settings for dermatological procedures, specifically targeting pigmented lesions and tattoos. The output allows for precise laser-tissue interaction, facilitating the removal or treatment of the indicated conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, functional features, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Laser surgical instrument; 755 nm wavelength; 50 ns nominal pulse width; Alexandrite rod medium; Q-switched; xenon flashlamp excitation; air-cooled system with distilled water head cooling; microprocessor-controlled; supports 2mm, 3mm, 4mm spot sizes; user-replaceable optical fiber delivery system.

Indications for Use

Indicated for the treatment of pigmented lesions and tattoos in patients requiring laser surgical 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 Q-Switched Alexandrite Laser (AlexLAZR) (K955662)
• Candela Q-Switched Alexandrite Laser (AlexLAZR) (K950831)

Submission Summary (Full Text)

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K063073

# 510(k) Summarv

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 100k) summary have been provided in conformance with 21 CFR §807.92.

#### Submitter Information

| Company Name: | Candela Corporation | DEC 20 2006 |
|------------------------|----------------------------------------------------|-------------|
| Company Address: | 530 Boston Post Road<br>Wayland, MA 01778 | |
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey Roberts<br>Manager, Regulatory Affairs | |
| Date summary Prepared: | 10/05/06 | |
| Device Identification | | |

Device Trade/Proprietary Name: The Candela Family of Q-Switched Alexandrite Laser

| | | (AlexLAZR) systems |
|----------------------------|--|--------------------------------------------------------------------------------------|
| Common Name: | | Q-Switched Alexandrite Laser |
| Classification Name: | | Laser Surgical Instrument, for use in General and Plastic<br>Surgery and Dermatology |
| Classification Regulation: | | 21 CFR § 878.4810 |
| Device Classification: | | II |

#### Identification of Predicate Device

| Predicate Device(s): | Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662 |
|----------------------|----------------------------------------------------------|
| | Candela Q-Switched Alexandrite Laser (AlexLAZR), K950831 |

### Device Description

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the contril bronnel. which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.

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The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.

A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems supports 2mm, 3mm, and 4mm nominal spot sizes.

#### Description of Intended Use

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in the following uses:

Pigmented Lesions Tattoos

#### Rationale for Substantial Equivalence

The Candela Family of O-Switched Alexandrite Laser (Alexi.AZR) systems, has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) , as the predicate devices.

The Candela Family of Q-Switched Alexandrite Laser (Alex) systems shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the currently legally marketed Candela Q-Switched Alexandrite Laser, (AlexLAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexLAZR), K95083 predicate devices.

#### Safety and Effectiveness Information

The Candela Family of Q-Switched Alexandrite Laser (Alex(AZR) systems is substantial equivalent to the currently legally marketed Candela O-Switched Alexandrite Laser, (AlexyAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexiAZR), K950831 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela Family of Q-Switched Alexandrite Laser (Alex147R) systems

#### Conclusion

Base on the similarities in indications for use, design features, and functional features the Candela Family of O-Switched Alexandrite Laser (Alex(AZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 0 2006

Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778

Re: K063073

Trade/Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems 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: October 5, 2006 Received: October 10, 2006

Dear Mr. Roberts:

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 - Mr. Jeffrey Roberts

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 premained nevice 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,

Mark N. Melkerson 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

510(k) Number (if known): K063073

Device Name: Candela Family of Q-Switched Alexandrite Leser (AlexyAzB) systems

Indications for Use:

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:

Pigmented Lesions Tattoos

> Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NELDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | 4663073 |
|---------------|---------|
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