STARLUX PULSED LIGHT SYSTEM

K033549 · Palomar Medical Products, Inc. · GEX · Mar 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033549
• Device Name: STARLUX PULSED LIGHT SYSTEM
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StarLux™ is a light-based medical device designed for effective removal of unwanted hair, permanent hair reduction, and the treatment of vascular and pigmented lesions.

Device Story

StarLux™ is a light-based medical device consisting of a base unit and interchangeable handpiece attachments. It delivers pulsed light to the skin to target hair follicles and vascular/pigmented lesions. Used in clinical settings by healthcare professionals. The device provides therapeutic light energy to achieve hair reduction and lesion treatment. It serves as a versatile platform for dermatological procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Light-based medical device; base unit with handpiece attachments; pulsed light energy source. Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for removal of unwanted hair (skin types I-VI) and stable long-term or permanent hair reduction; treatment of benign pigmented lesions (lentigines, nevi, melasma, café-au-lait); and treatment of vascular lesions (port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins).

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™ Pulsed Light System
• Lumenis VascuLight (Family of IPL)

Submission Summary (Full Text)

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K 033549

## Attachment 5

## 510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the Palomar StarLux™ Pulsed Light System 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: | November 10, 2003 |
| Device Trade Name: | Palomar StarLux™ |
| 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 Device: | EsteLux™ Pulsed Light System<br>Lumenis VascuLight (Family of IPL) |
| System Description: | The StarLux™ is a versatile, light-based medical<br>device consisting of a base unit and handpiece<br>attachments. |
| Intended Use of the Device: | The StarLux™ is a light-based medical device<br>designed for effective removal of unwanted hair,<br>permanent hair reduction, and the treatment of<br>vascular and pigmented lesions. |

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| Performance Data: | The differences in the specifications of the<br>StarLux™ and the predicate devices do not result<br>in different performance or raise new questions of<br>safety or efficacy. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the foregoing, the StarLux™ System is<br>substantially equivalent to the legally-marketed<br>claimed predicate devices, i.e., the EsteLux™ and<br>VascuLight. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 131 Kelekent Lane Cary, North Carolina 27511

Re: K033549 Trade/Device Name: Palomar StarLux™ 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: January 30, 2004 Received: February 3, 2004

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 sct 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), 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(clia 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 STATEMENT

510(K) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: StarLux™M

Indications for Use:

The StarLux™ Pulsed Light system is indicated for:

- The removal of unwanted hair from skin types I-VI, and to . effect stable long-term, or permanent, hair reduction.
- The treatment of benign pigmented lesions, including � lentigines, nevi, melasma, and café-au-lait.
- The treatment of vascular lesions, including port wine stains, . hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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

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Muriam C. Provost

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

**510(k) Number** K633549