PALOMAR ERBIUM HANDPIECE

K071152 · Palomar Medical Products, Inc. · GEX · May 25, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071152
• Device Name: PALOMAR ERBIUM HANDPIECE
• Applicant: Palomar Medical Products, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Special
• 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, telangicctasia, 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

Palomar Erbium Handpiece is an accessory for the StarLux Pulsed Light and Laser System. System includes cart, console, chiller, footswitch, and handpiece. Device delivers laser energy to soft tissue for coagulation, vaporization, ablation, and cutting. Used by clinicians in dermatology and plastic surgery settings. Output is laser energy; clinical effect is tissue modification for aesthetic and surgical procedures (e.g., resurfacing, scar revision, lesion removal). Benefits include precise tissue management for various dermatological conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Erbium laser surgical instrument. Attaches to StarLux system console. Energy source: laser. Form factor: handpiece. Intended for soft tissue surgery (21 CFR 878.4810).

Indications for Use

Indicated for surgical 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/superficial lesions. Prescription use only.

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

• Lux2940 Handpiece (K063571)

Submission Summary (Full Text)

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## 510(k) Summary Palomar Erbium Handpiece

K071152

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 Phone: [phone] Fax: [phone]

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

DATE PREPARED: April 24, 2007

#### 2. DEVICE INFORMATION

| TRADE/PROPRIETARY NAME: | Palomar Erbium Handpiece |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Erbium Laser |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21 CFR §878.4810) |
| PRODUCT CODE: | GEX |

#### 3. PREDICATE DEVICE

Lux2940 Handpiece K063571 Palomar Medical Technologies, Inc.

#### 4. INTENDED USE

Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, telangicctasia, 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.

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#### DEVICE DESCRIPTION 5.

The Palomar Erbium Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a System. footswitch, and a handpiece.

#### PERFORMANCE DATA 6.

The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device.

#### 7. SUBSTANTIAL EQUIVALENCE

The Palomar Erbium Handpiece was found to be substantially equivalent to its predicate device when used according to its intended use. The information that is provided in this application demonstrates that the Palomar Erbium Handpiece also shares the same technological characteristics as its predicate.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food 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

Re: K071152

Trade/Device Name: Palomar Erbium 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: April 24, 2007 Received: April 26, 2007

MAY 2 5 2007

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, "Mishranding 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,
Mark McMahon

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Palomar Erbium Handpiece

Indications for Use:

The Palomar Erbium 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 .

Mark A. Miller

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

510(k) Number K071152

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)