MOSAIC LASER SYSTEM

K070392 · Lutronic Corporation · GEX · Jul 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070392
• Device Name: MOSAIC LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOSAIC Laser System is indicated for dermatological procedures requiring the coagulation of soft tissue.

Device Story

MOSAIC Laser System; self-contained console with Er-GLASS fiber laser module, touch LCD, handpiece, and footswitch. Produces coherent 1550 nm infrared light beam. Physician-operated in clinical setting. Physician controls laser pulse power and selects handpiece tip (5 mm, 6 mm, 8 mm, 10 mm) to optimize effect for specific dermatological applications. System includes embedded processor for control, key switch, and emergency stop. Device provides soft tissue coagulation; benefits patient through targeted dermatological treatment.

Clinical Evidence

Human and animal performance data provided. Histological response to the MOSAIC laser was compared to the predicate device, demonstrating substantial equivalence in tissue coagulation effects.

Technological Characteristics

Er-GLASS fiber laser module; 1550 nm wavelength; coherent infrared light. System includes console, optical fiber delivery, and footswitch. Handpiece tips available in 5, 6, 8, and 10 mm sizes. Embedded processor for system control. Touch LCD interface. Powered laser surgical instrument.

Indications for Use

Indicated for dermatological procedures requiring the coagulation of soft tissue in patients requiring such treatment.

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

• Fraxel SR Laser System (K053047)
• Fraxel II SR Laser System and Accessories (K060310)

Submission Summary (Full Text)

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# 510(k) Summary for the Lutronic Corporation MOSAIC Laser System

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## 1. General Information

| Submitter: | Lutronic Corporation<br>#403-2,3,4, Ilsan Technotown<br>1141-1 Baeksok-Dong, Ilsan-Gu<br>Goyang-Si, Gyeonggi-Do, 410-722<br>Republic of Korea |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | July 11, 2007 |
| Names: | |
| Device Name: | MOSAIC Laser System |

Classification Name:

Laser Instrument, Surgical, Powered Product Code: GEX Panel : General & Plastic Surgery

## 3. Predicate Devices

2.

The MOSAIC Laser System is substantially equivalent to a combination of the Fraxel SR Laser System (K053047) and the Fraxel II SR Laser System and Accessories (K060310).

# 4. Device Description

The MOSAIC Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The MOSAIC produces a beam of coherent infrared (1550 nm) light. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip (5 mm, 6 mm, 8 mm, and 10 mm).

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The system console is the heart of the MOSAIC Laser System and contains the optical system (Er-GLASS Fiber Laser Module), Touch LCD, handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD.

#### 5. Indications for Use

The MOSAIC Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

### 6. Performance Data

Human and animal performance data was provided which documented that the histological response to the MOSAIC was substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

JUL 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

O'Connell Regulatory Consultants, Inc. % Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K070392

Trade/Device Name: MOSAIC Laser System 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: July 2, 2007 Received: July 3, 2007

Dear Ms. O'Connell:

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

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Page 2 - Ms. Maureen O'Connell

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, 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,

Mark N. Mello

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: _________________________________________________________________________________________________________________________________________________________________

### Indications for Use:

The MOSAIC Laser System is indicated for dermatological procedures requiring the coagulation of soft tissue.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use (Part 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)

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

*100(k) **Number** K07032