PALOMAR LUX2940 HANDPIECE

K063571 · Palomar Medical Technologies, Inc. · GEX · Feb 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063571
• Device Name: PALOMAR LUX2940 HANDPIECE
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, Telangiectasia, spider veins, actinic chelitis, keloids, Verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions

Device Story

Lux2940 is an Er:YAG laser handpiece; part of a system including console, cooling system, and power supply. Used by clinicians for soft tissue surgery, including skin resurfacing and lesion removal. Device delivers laser energy to target tissue; causes ablation, vaporization, or coagulation. Clinical benefit includes precise tissue management for dermatological and surgical conditions. Operated by physicians in clinical settings.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Er:YAG laser surgical instrument. System includes console, cooling system, power supply, and handpiece. Operates as a laser surgical instrument for general/plastic surgery and dermatology (21 CFR 878.4810).

Indications for Use

Indicated for surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue, including skin, cutaneous/subcutaneous tissue, muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, and glands. Specific applications include skin resurfacing, wrinkle treatment, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, and debulking of benign tumors, cysts, and superficial lesions.

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

• Friendly Light (K000023)
• Contour Profile (K010285 & K040005)
• Harmony Lovely II (K042000)
• Dermablate (K980361)

Submission Summary (Full Text)

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K063571

# 510(k) Summary Lux2940 Handpiece

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

#### 1. SUBMITTER'S INFORMATION

- NAME:
Palomar Medical Technologies, Inc.

82 Cambridge Street ADDRESS: Burlington, MA 01803 FEB Phone: [phone] Fax: [phone]

9 2007

7

Sharon Timberlake, RAC, CCRA CONTACT: Director of Regulatory Affairs

DATE PREPARED: November 28, 2006

#### 2. DEVICE INFORMATION

Palomar Lux2940 Handpiece TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME: Er: YAG laser

CLASSIFICATION NAME:

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR §878.4810)

GEX PRODUCT CODE:

#### PREDICATE DEVICES 3.

Friendly Light (K000023) Innotech USA

Contour Profile (K010285 & K040005) Sciton, Inc.

Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.)

Dermablate (K980361) Aesculap-Meditec

{1}------------------------------------------------

#### 4. INTENDED USE

Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, Telangiectasia, spider veins, actinic chelitis, keloids, Verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions

#### DEVICE DESCRIPTION ട്.

The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.

#### 6. PERFORMANCE DATA

・

The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.

#### 7. SUBSTANTIAL EQUIVALENCE

The Lux2940 handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the Lux2940 also share the same technological characteristics to its predicates.

2/2

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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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus in its talons.

ood 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

9 2007 FB

Re: K063571 Trade/Device Name: Palomar Lux2940 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 29, 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.

For Pablo Perez

Mark N. Melkerson 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): ___K063571

Device Name: Palomar Lux2940 Handpiece

Indications for Use:

The Palomar Lux2940 handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:

- Skin resurfacing .
- Treatment of wrinkles .
- Epidermal nevi .
- Telangiectasia .
- Spider veins ●
- Actinic chelitis .
- Keloids .
- Verrucae .
- Skin tags .
- Anal tags .
- Keratoses .
- Scar revision (including acne scars) .
- Debulking benign tumors .
- Debulking cysts .
- Superficial skin lesions �

(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 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|--------------------------|
| | OR |
| 510(k) Number | K063577 |
| | Over-The-Counter Use |
| | (Optional Format 1-2-96) |

PALOMAR MEDICAL TECHNOLOGIES, INC. Lux2940 510(K)

CONFIDENTIAL