EMERGE FRACTIONAL LASER

K111840 · Palomar Medical Products, Inc. · ONG · Nov 14, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111840
• Device Name: EMERGE FRACTIONAL LASER
• Applicant: Palomar Medical Products, Inc.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Nov 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Device Story

Emerge Fractional Laser is a fractional laser system comprising a handpiece and base unit with power supply, control electronics, and LCD interface. Device delivers fractional laser energy to skin to induce coagulation of soft tissue and resurfacing. Used in clinical settings by healthcare professionals for treating pigmented lesions and facial wrinkles. Output is controlled laser energy; provider monitors treatment via interface to adjust parameters. Benefits include improved skin appearance through resurfacing and lesion reduction.

Clinical Evidence

The submission relies on clinical data, histology data, and verification/validation information to support substantial equivalence. No specific study metrics (e.g., p-values, sensitivity) are detailed in the provided summary.

Technological Characteristics

Fractional laser system consisting of a handpiece and base unit. Includes power supply, control electronics, and LCD user interface. Operates as a laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation and skin resurfacing, including treatment of pigmented lesions (lentigos, solar lentigos, melasma, dyschromia) and facial wrinkles/fine lines.

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 Icon™ Aesthetic System Lux1440 Handpiece (K103664)
• Palomar LOI System (PaloVia™) (K090525)
• Reliant Technologies, Inc. Fraxel IV SR Laser System (Re:fine™) (K063808)
• Solta Medical, Inc. Clear+Brilliant Laser System (K110349)

Submission Summary (Full Text)

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K111840

## NOV 1 4 2011

### 510(k) Summary

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

#### SUBMITTER'S INFORMATION 1.

| NAME: | Palomar Medical Technologies, Inc. |
|----------|------------------------------------------------------------------------------------------|
| ADDRESS: | 15 Network Drive<br>Burlington, MA 01803<br>Phone: [phone]<br>Fax: [phone] |
| CONTACT: | Sharon Timberlake, MSHS, RAC, CCRA<br>Director of Regulatory Affairs |

DATE PREPARED: November 7, 2011

#### 2. DEVICE INFORMATION

| TRADE/PROPRIETARY NAME: | Emerge Fractional Laser |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Light and Laser System |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21 CFR § 878.4810) |
| PRODUCT CODES: | GEX, ONG |

#### PREDICATE DEVICES 3.

Palomar Medical Technologies, Inc. Palomar Icon™ Aesthetic System Lux1440 Handpiece K103664

Palomar Medical Technologies, Inc. LOI System (PaloVia™) K090525

Reliant Technologies, Inc. (Now Solta Medical, Inc.) Fraxel IV SR Laser System (Re:fine™) K063808

Solta Medical, Inc. Clear+Brilliant Laser System K110349

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#### 4. INTENDED USE

The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

#### న. DEVICE DESCRIPTION

The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.

#### 6. SUBSTANTIAL EQUIVALENCE

The Emerge Fractional Laser is substantially equivalent to its predicate devices when used according to its intended use. The review of the technological characteristics, mechanism of action, indications for use, clinical data, histology data, and verification as well as validation information provided in the 510(k) Premarket Notification demonstrates that the Emerge Fractional Laser is substantially equivalent to its predicate device. Thus, substantial equivalence is therefore justified.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 4 2011

Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 15 Network Drive Burlington, Massachusetts 01803

Re: K111840

Trade/Device Name: Emerge Fractional Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG Dated: November 07, 2011 Received: November 09, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Sharon Timberlake, MSHS, RAC, CCRA

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melke Director Division of Surgical, Orthopedic and Restorative 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: Emerge Fractional Laser

Indications for Use:

The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ryde for mkrg

(Division Sign-Cil) Division of Surgical, Orthopedic, and Restorative Devices

11 1840 510(k) Number.

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PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): EMERGE FRACTIONAL LASER CONFIDENTIAL PAGE 1