POWERLIPO LASER SYSTEM

K082096 · Lutronic Corporation · GEX · Oct 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082096
• Device Name: POWERLIPO LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerLipo Laser System in indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.

Device Story

PowerLipo Laser System is a surgical Nd:YAG laser console used for soft tissue procedures and laser-assisted lipolysis. System comprises a console, optical fiber delivery system, and footswitch. Console houses Nd:YAG optical system, laser controls, embedded processor, and power supply. Operated by physicians in clinical settings. Laser energy is delivered via fiber handpiece to target tissue for incision, excision, vaporization, ablation, or coagulation. Emergency stop and key switch provide safety controls. Output allows precise tissue management; benefits include controlled thermal effects for surgical and lipolysis applications.

Clinical Evidence

No clinical data presented.

Technological Characteristics

Nd:YAG laser system; includes console, optical fiber delivery system, and footswitch. Features embedded processor for system control. Energy source is laser radiation. Standalone device.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (skin, muscle, organs, etc.) and laser-assisted lipolysis in patients requiring such procedures.

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

• SmartLipo Laser System
• SmartLipo Multiwavelength Laser System
• Cynosure YAG MIR II Laser
• CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser

Submission Summary (Full Text)

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# OCT 0 8 2008

# 510(k) Summary for the Lutronic Corporation PowerLipo Laser System 〈〈▽ 8 2 09 b

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 21, 2008 |

2. Names

| Device Name: | PowerLipo Laser System |
|----------------------|----------------------------------------------------------------------------------------------|
| Trade Name: | PowerLipo |
| Classification Name: | Laser Instrument, Surgical, Powered<br>Product Code: GEX<br>Panel: General & Plastic Surgery |

#### 3. Predicate Devices

The PowerLipo Laser System is substantially equivalent to a combination of the SmartLipo Laser System, the SmartLipo Multiwavelength Laser System, the Cynosure YAG MIR II Laser and the CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser.

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#### 4. Device Description

The PowerLipo Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the PowerLipo Laser System and contains the Nd-YAG optical system, laser system control, fiber delivery system with 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 FND display.

#### 5. Indications for Use

The PowerLipo Laser System is indicated for use the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.

### 6. Performance Data

None presented.

18

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 8 2008

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

Re: K082096

Trade/Device Name: PowerLipo Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Code: GEX Dated: July 21, 2008 Received: July 24, 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, 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 (OS) 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 Postmarket Surveillance at [phone]. For questions regarding 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 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 Wilkerson

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): | K082096 |

PowerLipo Laser System Device Name:

### Indications for Use:

The PowerLipo Laser System in indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.

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

Over The Counter Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

**510(k) Number** K082096