MOSAIC ECO2 LASER SYSTEM

K080496 · Lutronic Corporation · GEX · Jul 7, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080496
• Device Name: MOSAIC ECO2 LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

Device Story

MOSAIC eCO2 Laser System is a CO2 laser (10.6um wavelength) for dermatological procedures; includes console, articulated arm, scanner handpiece, and footswitch. Operates in static or dynamic modes; laser energy absorbed by tissue water causes instantaneous vaporization for ablation, resurfacing, and coagulation. Physician-operated in clinical settings; power and scan patterns adjusted to optimize treatment for specific skin conditions. Benefits include precise tissue removal and resurfacing for aesthetic and dermatological improvements.

Clinical Evidence

No clinical data presented.

Technological Characteristics

CO2 laser system; 10.6um wavelength; articulated arm delivery with scanner handpiece; static and dynamic operation modes; console-based; powered surgical laser instrument.

Indications for Use

Indicated for dermatological procedures requiring ablation, resurfacing, and coagulation of soft tissue, including treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia in patients requiring such dermatological care.

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

• Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)
• Sharplan Lasers, Inc. Model 1080 CO2 Surgical Laser System (K933918)
• Modified Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147)
• Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K071051)
• Cynosure, Inc. Smart CO2 (K031224)

Submission Summary (Full Text)

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K080496

#### 510(k) Summary for the 'JUL - 7 2008 Lutronic Corporation MOSAIC eCO2 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 1, 2008 |

#### 2. Names

MOSAIC eCO2 Laser System (Trade Name: MOSAIC eCO2) Device Name:

Classification Name:

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

#### 3. Predicate Devices

The MOSAIC eCO2 is substantially equivalent to the predicate devices, including the Lumenis, Inc. (Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) (K022060); the Sharplan Lasers, Inc. Model 1080 CO2 Surgical Laser System (K933918); the Lumenis, Inc. Modified Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147); the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K071051); and the Cynosure, Inc. Smart CO2 (K031224).

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### 4. Device Description

The MOSAIC eCO2 Laser System consists of a self-contained console, an articulated arm delivery system with scanner handpiece and a footswitch. The MOSAIC eCO2 produces a beam of coherent infrared light (10.6um) and has two operation modes (Static mode and Dynamic Mode). The laser works in medical applications because 10.6um is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. This heating causes instantaneous vaporization of the target tissue.

The MOSAIC eCO2 Laser System utilizes a CO2 tube to generate a laser beam with a wavelength of 10.6 um and uses a scanner handpiece. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different scan pattern.

## 5. Indications for Use

The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

- 6. Performance Data
None presented.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2008

Lutronic Corporation % O'Connell Regulatory Consultants Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K080496 Trade/Device Name: MOSAIC eCO2 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: June 16, 2008 Received: June 17, 2008

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. 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

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities mader 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 M. Mcllveen

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): ____________________________________________________________________________________________________________________________________________________ K080496

Device Name: _ _ _ _ _ MQSAIC eCO2 Laser System ______________________________________________________________________________________________________________________________

#### Indications for Use:

The MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

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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Varlare Buessy
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K050496