PALOMAR LUXG HANDPIECE

K020941 · Palomar · GEX · Jun 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020941
• Device Name: PALOMAR LUXG HANDPIECE
• Applicant: Palomar
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EsteLux™ System is intended for effective treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI).

Device Story

LuxG handpiece is an accessory to the EsteLux Pulsed Light System; a light-based medical device. It delivers light energy to treat facial and leg veins and benign pigmented lesions. Used in clinical settings by healthcare professionals. The device functions by applying light to the skin to achieve photocoagulation and photothermolysis of target vascular and pigmented structures. It benefits patients by providing a non-invasive treatment option for dermatological conditions across all skin types (I-VI).

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of specifications to legally marketed predicate devices.

Technological Characteristics

Light-based medical device accessory; pulsed light delivery for photothermolysis/photocoagulation. Designed for use with the EsteLux Pulsed Light System. No specific materials, software architecture, or connectivity details provided.

Indications for Use

Indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions in all skin types (I-VI).

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

• EsteLux Standard handpiece
• Lumenis (ESC) Quantum SR

Submission Summary (Full Text)

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## Attachment 5

K b2094J

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the LuxG™ handpiece is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Palomar Medical Technologies, Inc. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 82 Cambridge St.<br>Burlington, MA 01803<br>781-993-2300 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | February 6, 2002 |
| Device Trade Name: | Palomar LuxGTM |
| Common Name: | LuxGTM |
| Classification Name: | Laser surgical instrument for use in General and<br>Plastic Surgery and in Dermatology<br>(see: 21 CFR 878-4810).<br>Product Code: GEX<br>Panel: 79 |
| Legally-Marketed Predicate Device: | EsteLux Standard handpiece<br>Lumenis (ESC) Quantum SR |
| System Description: | The LuxGTM handpiece is an accessory to the<br>EsteLux Pulsed Light System, a light-based medical<br>device designed for effective treatment of facial and<br>leg veins, and treatment of pigmented lesions in all<br>skin types (I-VI). |
| Intended Use of the Device: | The EsteLux™ System is intended for effective<br>treatment of facial and leg veins, and treatment of<br>pigmented lesions in all skin types (I-VI). |

CONFIDENTIAL AND PROPRIETARY

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Performance Data:

The differences in the specifications of the EsteLux LuxG™, the EsteLux Standard handpiece and the Quantum SR do not result in different performance or raise new questions of safety or efficacy.

Conclusion:

Based on the foregoing, the LuxGTM handpiece is substantially equivalent to the legally-marketed claimed predicate devices.

## CONFIDENTIAL AND PROPRIETARY

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Inc. 131 Kelekent Lane Cary, NC 27511

JUN 1 9 2002

Re: K020941 Trade/Device Name: LuxGTM Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 21, 2002 Received: March 22, 2002

Dear Ms. Moore:

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. Marcy Moore

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Stupt Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Corrected Pages

## INDICATIONS FOR USE STATEMENT

K 020941 510(K) Number:

LuxGTM Device Name:

Indications for Use:

The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-the-Counter Use (per-21 CFR 801.109)

Sturt Rhodes

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

KOZO941 510(k) Number _

CONFIDENTIAL AND PROPRIETARY

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