PALOMAR LUXV HANDPIECE

K040081 · Palomar Medical Technologies, Inc. · GEX · Apr 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040081
• Device Name: PALOMAR LUXV HANDPIECE
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EsteLuxTM System with the LuxVTTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).

Device Story

The EsteLux Pulsed Light System with LuxVT handpiece is a light-based medical device used for the treatment of inflammatory acne. Operated by healthcare professionals in a clinical setting, the device delivers pulsed light to the skin. The light energy targets acne lesions to provide therapeutic benefit. The system is used as an adjunct or primary treatment for acne vulgaris. Clinical decision-making is supported by the device's ability to deliver controlled light therapy, potentially reducing acne inflammation and improving patient outcomes.

Clinical Evidence

Clinical data was provided to support the safety and efficacy of the LuxVT handpiece. No specific study metrics, sample sizes, or p-values were detailed in the provided summary.

Technological Characteristics

Light-based medical device (pulsed light). Handpiece accessory for the EsteLux Pulsed Light System. Classified as a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for the treatment of inflammatory acne (acne vulgaris) in patients.

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

• ClearTouch by Radiancy
• Candela Smoothbeam
• Laserscope Aura
• ICN Photonics NLite

Submission Summary (Full Text)

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## Attachment 5

K040081

510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the LuxVM 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: | January 12, 2004 |
| Device Trade Name: | Palomar LuxVTTM Handpiece |
| Common Name: | LuxVTTM |
| 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: | ClearTouch by Radiancy; Candela Smoothbeam;<br>Laserscope Aura; ICN Photonics NLite |
| System Description: | The EsteLux Pulsed Light System with the LuxVTTM<br>handpiece accessory is a light-based medical device<br>designed for treatment of inflammatory acne. |
| Intended Use of the Device: | The EsteLuxTM System with the LuxVTTM handpiece<br>is intended for the treatment of inflammatory acne<br>(acne vulgaris). |

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Performance Data:

The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece.

Conclusion:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2004

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

Re: K040081 Trade/Device Name: LuxVTM 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 13, 2004 Received: January 15, 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. Iisting 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), 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

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 STATEMENT

X 040081 510(K) Number:

LuxVIM Device Name:

Indications for Use:

The LuxV™ handpiece is intended for the treatment of inflammatory acne (acne vulgaris).

(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)

Muriam C. Provost

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

8040081 510(k) Number_