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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Lutronic Corporation AccuSculpt II Laser System, based on the provided document:

This 510(k) summary explicitly states: "No performance data was provided since no new questions of safety or efficacy have been raised."

Therefore, the device's acceptance was based on substantial equivalence to predicate devices rather than new performance data or a specific study proving it meets acceptance criteria. The document does not contain information on acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details.

Here's a breakdown of the requested information, noting what is present and what is absent in the document:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified.	Not specified.
(No new performance data was provided as the device was deemed substantially equivalent to predicate devices.)	(No new performance data was provided.)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or performance study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth was established for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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
- No. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a laser system, not an algorithm. No standalone performance study was conducted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no performance study was conducted.
The sample size for the training set
- Not applicable. No training set was used as no new algorithm or performance study was conducted.
How the ground truth for the training set was established
- Not applicable. No training set or ground truth was established.

Summary of Device Acceptance Rationale:

The AccuSculpt II Laser System gained 510(k) clearance based on substantial equivalence to previously cleared predicate devices:

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

The submission explicitly states that the AccuSculpt II Laser System "has the same indications for use, technological characteristics and principles of operation as the predicate devices." Because of this, it was determined that "no new questions of safety or efficacy have been raised," and therefore, no new performance data or clinical studies were required or provided for this 510(k) submission.

Summary

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101573
Page 1 of (2)

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: 978-207-1245 Fax: 978-824-2541

Summary Preparation Date:

June 4, 2010

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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101573
Page 2 of 2

4. Device Description

5. Indications for Use

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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 (800) 638-2041 or (301) 796-7100 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)

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Nil RPOgden for nxm

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

510(k) Number K 101573

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.