ERBIUM FRACTIONAL HANDPIECE

K083900 · Palomar Medical Products, Inc. · GEX · Feb 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083900
• Device Name: ERBIUM FRACTIONAL HANDPIECE
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.

Device Story

Erbium Fractional Handpiece is a laser surgical instrument accessory for the StarLux Pulsed Light and Laser System. It performs soft tissue ablation, coagulation, and skin resurfacing. The system includes a cart, console, chiller, footswitch, and the handpiece. Operated by a physician in a clinical setting, the device delivers laser energy to the skin to treat aesthetic conditions like wrinkles and pigmented lesions. The provider uses the handpiece to target specific skin areas, facilitating tissue resurfacing and coagulation, which can improve skin texture and appearance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dermatological Erbium laser handpiece; attaches to StarLux Pulsed Light and Laser System console; includes chiller and footswitch; laser surgical instrument (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, pigmented lesions, and vascular dyschromia.

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 Erbium Handpiece (K071152)
• Palomar Erbium Handpiece (K063571)
• Lux1540 Fractional Handpiece (K080244)

Reference Devices

• Fraxel III SR Laser System (Fraxel Re:Pair™) (K080915)

Submission Summary (Full Text)

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K083960

# FEB 2-7 2009

## 510(k) Summary Erbium Fractional Handpiece

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

#### 1. SUBMITTER'S INFORMATION

Palomar Medical Technologies, Inc. NAME:

82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: [phone] Fax: [phone]

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

DATE PREPARED: February 5, 2009

#### 2. DEVICE INFORMATION

Erbium Fractional Handpiece TRADE/PROPRIETARY NAME:

Dermatological Erbium Laser Common/Usual Name:

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

GEX Product Code:

#### PREDICATE DEVICES 3.

Palomar Medical Technologies, Inc. Palomar Erbium Fractional Handpiece K071768

Palomar Medical Technologies, Inc. Palomar Erbium Handpiece K071152, K063571

Palomar Medical Technologies, Inc. Lux1540 Fractional Handpiece K080244

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# 083900

Reliant Technologies. Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) K080915

#### INTENDED USE 4.

The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.

#### న్. DEVICE DESCRIPTION

The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a Systems. footswitch, and a handpiece.

#### PERFORMANCE DATA 6.

The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in Thus, it does not result in additional safety or premarket notification. effectiveness information.

#### SUBSTANTIAL EQUIVALENCE 7.

The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates.

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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 & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA 82 Cambridge Street Burlington, Massachusetts

FEB 2 7 2009

Re: K083900

Trade/Device Name: Erbium Fractional 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: December 24, 2008 Received: December 29, 2009

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 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 - Sharon Timberlake, MSHS, RAC, CCRA

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. Mulheran

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): _KO8 3 900

Device Name: Erbium Fractional Handpiece

Indications for Use:

The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Milne Bylin for mxm

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

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510(k) Number K083900

PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): ERBIUM FRACTIONAL HANDPIECE