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.

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.

AI/ML Overview

This document is a 510(k) Summary for the Lutronic Corporation PowerLipo Laser System, submitted to the FDA in 2008. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document because it explicitly states:

"6. Performance Data: None presented."

This indicates that a study demonstrating the device's performance against specific acceptance criteria, as one might find for a novel device or a device requiring clinical trials, was not included or required for this 510(k) submission.

Here's a breakdown of what can be inferred or directly stated based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "Performance Data: None presented." This implies that specific acceptance criteria and a study demonstrating the device's performance against those criteria were not part of this 510(k) submission. The FDA clearance was based on substantial equivalence to predicate devices, not on a new performance study for this specific device.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable. No test set or corresponding data is described because no performance data was presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No test set or ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a laser system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a laser system, not an algorithm. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. No ground truth for performance evaluation is described.

8. The Sample Size for the Training Set

Not applicable. This device is a laser system, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or ground truth establishment is relevant for this type of device and submission.

In summary, the 510(k) Summary explicitly states "Performance Data: None presented," meaning the requested information regarding performance criteria and studies is not contained within this document. The clearance for the PowerLipo Laser System was based on its substantial equivalence to existing legally marketed predicate devices.

Summary

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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#403-2,3,4, Ilsan Technotown1141-1 Baeksok-Dong, Ilsan-GuGoyang-Si, Gyeonggi-Do, 410-722Republic of Korea
Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864Telephone: 978-207-1245Fax: 978-824-2541
Summary Preparation Date:	July 21, 2008

Names

Device Name:	PowerLipo Laser System
Trade Name:	PowerLipo
Classification Name:	Laser Instrument, Surgical, PoweredProduct Code: GEXPanel: 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

5. Indications for Use

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 & 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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)

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

510(k) Number K082096

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.