LUX1540, LUX1440 & LUX2940 LASER HANDPIECES

K101506 · Palomar Medical Technologies, Inc. · ONG · Sep 1, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101506
• Device Name: LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Sep 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lux 1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions. The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

Device Story

Dermatological laser system consisting of cart, console, chiller, footswitch, and interchangeable handpieces (Lux1540, Lux1440, Lux2940). System delivers fractional laser energy to skin for coagulation, resurfacing, and ablation. Operated by clinicians in dermatological settings. Combined treatment protocols (Lux1540/Lux2940 or Lux1440/Lux2940) allow for multi-modal tissue interaction. Output enables skin resurfacing and correction of textural/pigment irregularities. Benefits include improved skin appearance and texture.

Clinical Evidence

Clinical studies evaluated safety and effectiveness of combined fractional treatments (Lux1540/Lux2940 or Lux1440/Lux2940) for wrinkles, dyschromia, and pigmented lesions. Results supported substantial equivalence to predicate devices.

Technological Characteristics

Fractional laser surgical handpieces for dermatological use. System includes console, power supply, chiller, and footswitch. Energy delivery via laser-tissue interaction for coagulation, resurfacing, and ablation. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, including treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia, and pigmented lesions.

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 Handpiece (Lux2940 Handpiece) (K100270, K083900, K071768, K071152, K063571)
• Palomar Medical Technologies, Inc. Lux1540 Handpiece (K100270, K090195, K091446, K080244, K060301)
• Palomar Medical Technologies, Inc. Lux1440 Handpiece (K100270, K073583, K091446)

Submission Summary (Full Text)

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K101506

### 510(k) Summary

SEP 1 2010

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

#### 1. SUBMITTER'S INFORMATION

مسمس

t

Palomar Medical Technologies, Inc. NAME:

ADDRESS: 15 Network Drive Burlington, MA 01803 Phone: [phone] Fax: [phone]

CONTACT: Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs

DATE PREPARED: June 24, 2010

#### 2. DEVICE INFORMATION

| TRADE/PROPRIETARY NAME: Lux 1540, Lux 1440, & Lux 2940 Handpieces |
|-----------------------------------------------------------------------|
| |

Dermatological and cosmetic laser COMMON/USUAL NAME:

CLASSIFICATION NAME:

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR § 878.4810)

Product Code: GEX. ONG

### 3. PREDICATE DEVICES

Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571

Palomar Medical Technologies, Inc. Lux1540 Handpiece K100270, K090195, K091446, K080244, K060301

Palomar Medical Technologies, Inc. Lux1440 Handpiece K100270, K073583, K091446

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101506

#### INTENDED USE 4.

The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

#### క. DEVICE DESCRIPTION

The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.

### PERFORMANCE DATA 6.

Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions. The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information.

#### 7. SUBSTANTIAL EQUIVALENCE

The Lux1540, Lux1440 and Lux2940 Handpieces are substantially equivalent to their predicate devices when used according to its intended use. This decision is based on the information that is provided in this 510(k) Premarket Notification which demonstrates that the handpieces share the same technological characteristics, mechanism of action, intended use and physical properties when compared to their predicates.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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1 2010

SEP

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 15 Network Drive Burlington, Massachusetts 01803

Re: K101506

Trade/Device Name: Lux1540. Lux1440 and Lux2940 Handpieces Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX, ONG Dated: June 28, 2010 Received: June 29, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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# Page 2 - Ms. Sharon Timberlake, MSHS, RAC, CCRA

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Chavala brehm

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K101506

### SEP 1. 2010

510(k) Number (if known):

Device Name: Lux1540, Lux1440 and Lux2940 Handpieces

Indications for Use:

The Lux 1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

Prescription Use X (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH, or

Barbara Buchan Dixon
(Division Sign-Off)

ion of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101506

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PALOMAR MEDICAL TECHNOLOGIES, INC. LUX1540, LUX1440 & ERBIUM FRACTIONAL HANDPIECES CONFIDENTIAL