ACCUSCULPT II LASER SYSTEM

K101573 · Lutronic Corporation · GEX · Sep 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101573
• Device Name: ACCUSCULPT II LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AccuSculpt II Laser System in indicated for the surgical incision, excision, vaporization, ablation, and coagulation of 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 AccuSculpt II is further indicated for laser assisted lipolysis.

Device Story

AccuSculpt II Laser System is a surgical Nd:YAG laser console; includes optical fiber delivery system, handpiece, footswitch, and embedded processor. Used by physicians in clinical settings for soft tissue surgery and laser-assisted lipolysis. Device transforms electrical power into laser energy for tissue interaction; operator controls parameters via console LCD and footswitch. Includes emergency stop and key switch for safety. Provides surgical precision for incision, excision, vaporization, ablation, and coagulation; benefits patients through minimally invasive lipolysis and soft tissue procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; includes console, optical fiber delivery system, handpiece, footswitch, and embedded processor. Features LCD display, key switch, and emergency stop button.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (skin, cutaneous/subcutaneous tissue, muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, glands) and laser-assisted lipolysis.

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

• Lutronic Corporation PowerLipo (AccuSculpt) Laser System (K082096)
• Sciton, Inc. Profile Multi-Platform System (K070388)

Submission Summary (Full Text)

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

# SEP 2 3 2010

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

## 1. General Information

Submitter: Lutronic Corporation #403-2,3,4, Ilsan Technotown 1141-1 Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea Contact Person: Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: [phone] Fax: [phone]

Summary Preparation Date:

June 4, 2010

2. Names

Trade Name:

Common Name:

Laser System

Classification Name:

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

AccuSculpt II Laser System

## 3. Predicate Devices

Lutronic Corporation PowerLipo (AccuSculpt) Laser System (K082096) Sciton, Inc. Profile Multi-Platform System (K070388)

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## 4. Device Description

The AccuSculpt II Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the AccuSculpt II 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 LCD display.

## 5. Indications for Use

The AccuSculpt II 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 AccuSculpt II is further indicated for laser assisted lipolysis.

## 6. Substantial Equivalence

The AccuSculpt II Laser System has the same indications for use, technological characteristics and principles of operation as the predicate devices. Therefore, the subject device is substantially equivalent to the previously cleared predicate devices.

## 7. Performance Data

No performance data was provided since no new questions of safety or efficacy have been raised.

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

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

SEP 2 3 2010

Re: K101573

Trade/Device Name: AccuSculpt II 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: Class II Product Code: GEX Dated: August 23, 2010 Received: August 24, 2010

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. 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 - Ms. Maureen O'Connell

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic Bi 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): | k101573 |
|---------------------------|----------------------------|
| Device Name: | AccuSculpt II Laser System |

SEP 2 3 2010## Indications for Use:

The AccuSculpt II Laser System in indicated for the surgical incision, excision, vaporization, ablation, and coagulation of 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 AccuSculpt II 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nil RPOgden for nxm

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

510(k) Number K 101573

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