PALOMAR STARLUX PULSED LIGHT SYSTEM

K041086 · Palomar Medical Products, Inc. · GEX · Jan 13, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041086
• Device Name: PALOMAR STARLUX PULSED LIGHT SYSTEM
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.

Device Story

StarLux Pulsed Light System is a broad-spectrum light-based medical device. It utilizes five interchangeable handpieces equipped with patented contact cooling technology to deliver light energy to target tissues. Operated by healthcare professionals in clinical settings, the device treats inflammatory acne and various cutaneous lesions. The system transforms electrical energy into pulsed light, which is applied to the skin surface. Contact cooling protects the epidermis during treatment. The output is controlled light pulses; clinical benefit is achieved through the therapeutic effect of light on acne and skin lesions. Healthcare providers use the device to perform dermatological procedures, with clinical decision-making based on the visual assessment of the patient's skin condition.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance data comparisons to legally marketed predicate devices.

Technological Characteristics

Broad-spectrum pulsed light system; features five interchangeable handpieces; incorporates patented contact cooling technology for epidermal protection. Device is a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for treatment of inflammatory acne (acne vulgaris) and benign pigmented epidermal and cutaneous lesions, including warts, scars, and striae in patients requiring light-based therapy.

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 EsteLux (K040081)
• Palomar StarLux (K033549)
• Palomar SpaLight (K003886)
• Lumenis IPL (K020839)

Submission Summary (Full Text)

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K041086/SCC1

JAN 1 3 2005

## Attachment 4

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the StarLux™ 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: | April 22, 2004 |
| Device Trade Name: | Palomar StarLux™ Pulsed Light System |
| Common Name: | StarLux™ |
| 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 Devices: | |

Palomar EsteLux (K040081) Palomar StarLux (K033549) Palomar SpaLight (K003886) Lumenis IPL (K020839)

System Description:

The StarLux Pulsed Light System is a broad spectrum light-based medical device designed for a wide range of clinical applications. The StarLux offers 5 handpieces with Palomar's patented contact cooling technology, each specifically designed for the optimal treatment of specific clinical indications.

CONFIDENTIAL AND PROPRIETARY

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K041086/SC01 p.28-

Intended Use of the Device: The StarLux™ System is intended for treatment of inflammatory acne and for the treatment of cutaneous lesions, including warts, scars and striae. Performance Data: The differences in the specifications of the StarLux™ and the predicates do not result in different performance or raise new questions of safety or efficacy. Conclusion: Based on the foregoing, the StarLux™ pulsed light system is substantially equivalent to the legally marketed claimed predicate devices.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511

Re: K041086 Trade/Device Name: StarLux™ Pulsed Light System 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: October 12, 2004 Received: October 21, 2004

Dear Ms. Moore:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications ferenced about and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreated)77, the enactment date of the Medical Device Amendments, or to commerce proc to they 20, 2017, 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). and Cosment Free (110.) that to novice, subject to the general controls provisions of the Act. The I ou may, develore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is classified (over a controls. Existing major regulations affecting your device can may be subject to back added of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou round in the Outs acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso oe aar nota a determination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I coolar statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or In the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty of events on (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) I mis lotter with and in your finding of substantial equivalence of your device to a legally promatics noticated 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,

Miriam C. Provost

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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## Indications for Use

K041086/SOO) 510(k) Number (if known):

Device Name: StarLux™ Pulsed Light System

Indications for Use:

The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.

× Prescription Use (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)

Muriam C. Provost

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

510(k) Number__Ko4/086