MODIFICATION TO PALOMAR LUX1540 HANDPIECE

K073583 · Palomar Medical Products, Inc. · GEX · Mar 26, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073583
• Device Name: MODIFICATION TO PALOMAR LUX1540 HANDPIECE
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar Lux1440 Handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

Device Story

Palomar Lux1440 Handpiece is a laser surgical instrument accessory designed for attachment to the StarLux Pulsed Light and Laser System. The system comprises a cart, base unit, chiller, footswitch, and the handpiece. It is used by clinicians in dermatological settings to perform skin resurfacing and soft tissue coagulation. The device delivers laser energy to the skin to achieve therapeutic effects. The clinician operates the system via the base unit controls and footswitch, monitoring the procedure directly. The output is the application of laser energy to the patient's skin, intended to benefit the patient through resurfacing or coagulation. The device is a modification of existing Palomar handpiece technology.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Laser surgical instrument; attaches to StarLux Pulsed Light and Laser System. Includes chiller and footswitch. Operates as a fractional laser delivery system for dermatological applications. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for skin resurfacing and dermatological procedures requiring soft tissue coagulation. Patient population not specified.

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

• Palomar Erbium Fractional Handpiece (K071768)
• Palomar Lux1540 Handpiece (K061652)

Submission Summary (Full Text)

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## Ko 7 35 83

### 510(k) Summary Palomar Lux1440 Handpiece

MAR 2 6 2008

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

#### SUBMITTER'S INFORMATION 1.

| NAME: | Palomar Medical Technologies, Inc. |
|----------|---------------------------------------------------------------------------------------------|
| ADDRESS: | 82 Cambridge Street<br>Burlington, MA 01803<br>Phone: [phone]<br>Fax: [phone] |
| CONTACT: | Sharon Timberlake, RAC, CCRA<br>Director of Regulatory Affairs |

DATE PREPARED: March 19, 2008

#### 2. DEVICE INFORMATION

| | TRADE/PROPRIETARY NAME: | Palomar Lux1440 Handpiece |
|----------------------|--------------------------------------------------------------------------------------------------------------|---------------------------|
| COMMON NAME: | Lux1440 | |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21 CFR §878.4810) | |
| PRODUCT CODE: | GEX | |

#### 3. PREDICATE DEVICE

Palomar Erbium Fractional Handpiece K071768 Palomar Medical Technologies, Inc.

Palomar Lux1540 Handpiece K061652 Palomar Medical Technologies, Inc.

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# Ko73583

#### 4. INTENDED USE

The Palomar Lux1440 Handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

#### DEVICE DESCRIPTION 5.

The Palomar Lux1440 Handpiece attaches to the StarLux Pulsed Light and Laser System. The complete system consists of a cart, base unit, chiller, a footswitch, and a handpiece.

#### PERFORMANCE DATA 6.

The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Lux1440 Handpiece is substantially equivalent to its predicate device.

#### 7. SUBSTANTIAL EQUIVALENCE

The Palomar Lux1440 Handpiece was found to be substantially equivalent to its predicate device when used according to its intended use. The information that is provided in this application demonstrates that the Palomar Lux1440 Handpiece also shares similar technological characteristics as its predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2008

Palomar Medical Technologies, Inc. % Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 93 Cambridge Street Burlington, Massachusetts 01803

Re: K073583 Trade/Device Name: PalmarLux 1440 Handpiece 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: February 15, 2008 Received: February 19, 2008

Dear Ms. Timberlake:

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 - Sharon Timberlake, RAC, CCRA

forth in the quality systems (OS) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark N. Wilkinson

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): K073583

Device Name: PalomarLux1440 Handpiece

Indications for Use:

Dermatological procedures requiring the coagulation of soft tissue;

Skin resurfacing procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K073583

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| Prescription Use | X |
| Over-The-Counter Use | |

(Per 21 CFR 801.109)

(Optional Format 1-2-96)