PALOMAR LUX1540 HANDPIECE

K061652 · Palomar Medical Products, Inc. · GEX · Feb 27, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K061652
• Device Name: PALOMAR LUX1540 HANDPIECE
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Palomar Lux1540 handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

Device Story

Lux1540 handpiece is an accessory to the StarLux Pulsed Light & Laser System; delivers 1540 nm wavelength light. System includes power source, chiller, footswitch, and umbilical-connected handpiece. Operates via fractional photothermolysis, creating a lattice pattern of microscopic islets of thermal damage in superficial skin layers. Used by physicians in clinical settings for skin resurfacing and soft tissue coagulation. Output allows controlled thermal injury to stimulate skin response. Benefits include clinical skin resurfacing outcomes.

Clinical Evidence

Clinical testing demonstrated the device performs fractional photothermolysis as intended. No new safety or effectiveness issues were identified.

Technological Characteristics

Laser surgical instrument (21 CFR 878.4810). Wavelength: 1540 nm. Delivery: Fractional photothermolysis (lattice pattern of microscopic islets). System components: Power source, chiller, footswitch, handpiece. Accessory to StarLux Pulsed Light & Laser System.

Indications for Use

Indicated for skin resurfacing and dermatological procedures requiring soft tissue coagulation. Prescription use only.

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

• Reliant Laser System (Fraxel SR Laser System) (K042319)
• Palomar Lux1540 handpiece (K060301)

Submission Summary (Full Text)

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# 510(K) Summary

K061652

This 510(K) Summary is being submitted in accordance with 21 CFR 807.92

Applicant:

Palomar Medical Technologies, Inc.
82 Cambridge St.
Burlington, MA 01803

Contact Person:

Sharon Timberlake, RAC, CCRA
Director of Regulatory Affairs
[phone]

Preparation Date:

June 12, 2006

Device Trade Name:

Palomar Lux1540 Handpiece

Common Name:

Lux1540

Classification Name:

Laser surgical instrument for use in General and Plastic Surgery
and Dermatology (21 CFR 878.4810)

Product Code:

GEX

Predicate Device:

Reliant Laser System (Fraxel SR Laser System) K042319
Palomar Lux1540 handpiece K060301

System Description:

The Palomar Lux1540 handpiece is an accessory to the
StarLux Pulsed Light & Laser System. The handpiece
delivers light with a wavelength of 1540 nm. The complete
system consists of a power source, chiller, a footswitch, and a
handpiece connected to the power unit with an umbilical.

Intended Use:

The Palomar Lux1540 handpiece is intended for skin
resurfacing procedures in addition to dermatological
procedures requiring the coagulation of soft tissue.

Performance:

Performance data was provided showing the Lux1540 is
capable of performing fractional photothermolysis, i.e.,
creation of a pattern (lattice) of microscopic islets of damage
at superficial skin layers. The results from the clinical testing
demonstrated that the Lux1540 performs as clinically
intended and that no new issues of safety or effectiveness
were present.

Substantial Equivalence:

The Palomar Lux1540 Handpiece is substantially equivalent
to its predicate device when indicated for skin resurfacing.
The data in this application demonstrates that the Palomar
Lux1540 handpiece shares the same indications for use,
similar design features, functional features, and therefore is
substantially equivalent

FEB 27 2007

substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES. USA

[Illustration of the Department of Health and Human Services logo]

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

FEB 2 7 2007

Re: K061652 Trade/Device Name: Palomar Lux 1540 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: November 27, 2006 Received: November 28, 2006

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 - Ms. Sharon Timberlake, 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 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,

Mark N. Melkerson
Director

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): K061652

Device Name: PalomarLux1540 Handpiece

Indications for Use:

Dermatological procedures requiring the coagulation of soft tissue;

Skin resurfacing procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

**510(k) Number** K061652

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

PALOMAR MEDICAL TECHNOLOGIES, INC. LUX1540 510(K): SKIN RESURFACING