The i-lipo™ System consists of a main unit, and applied parts consisting of various laser diode cluster probes and pads. The Main Unit contains the mains input, fuses, power supply, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The cluster probes and pads, which are placed against the patients skin, contain the Laser diodes. Laser energy promotes disruption of adipocyte cells within the fat layer for release of fat and lipids from these cells for non-invasive aesthetic use.

AI/ML Overview

The provided text describes the i-lipo™ device and its 510(k) summary, which includes information about its intended use, comparison to predicate devices, and clinical testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case study information, standalone algorithm performance, or ground truth details in the format requested.

The document primarily focuses on establishing substantial equivalence to predicate devices and states that "Randomised, blinded, placebo controlled circumferential reduction studies of the selected treatment area have been performed, which demonstrates the efficacy of the device..." without providing the numerical results or the specific criteria for demonstrating efficacy.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's what can be gathered, with significant gaps based on the absence of the requested data:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the document)	"demonstrates the efficacy of the device, following 8 sessions of treatment each of 20 minutes duration, delivered 2 to 3 times per week over a 3 week period. After each treatment session, a 30-40 minute cardiovascular exercise was completed, based upon the participants existing exercise regimen."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified.
Data Provenance: The study was "Randomised, blinded, placebo controlled circumferential reduction studies." The submitter is from the UK, so it's plausible the study was conducted there, but this is not explicitly stated. It was a prospective study.

3. 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 as the ground truth appears to be objective measurements (circumferential reduction) rather than expert interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not specified for the measurement of circumferential reduction.

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 low-level laser system for aesthetic treatment, not an AI diagnostic or interpretive device involving human readers.

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

Not applicable as this is a medical device, not an algorithm. The device performance (efficacy in reducing waist circumference) was evaluated directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth type was outcomes data, specifically the "circumferential reduction of the waist." This is a direct physical measurement.

8. The sample size for the training set

Not applicable. This is a medical device approval, not an AI algorithm development where a "training set" would be used in the same context. The study population for the clinical testing would be equivalent to the dataset used to demonstrate efficacy. The sample size for this dataset is not specified.

9. How the ground truth for the training set was established

Not applicable (see point 8). For the clinical study demonstrating efficacy, the ground truth (circumferential reduction) was established through direct measurement on study participants.

Summary

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Chromogenex Technologies Limited - i-lipo™ -Traditional 510(k) Application May 2011

510(k) Summary

MAR 2 3 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter: A. Chromogenex Technologies Limited Units 1-2 Heol Rhosyn Parc Dafen Llanelli Carmarthenshire SA14 8QG UK

Phone: +44 (0) 1554 755444 +44 (0) 1554 755333 Fax:

Contact: Mr Peter R Bevan (Quality Manager)

Date Prepared: May 2011

B. Device Names:

Classification name Low Level Laser System for Aesthetic Use Common/usual name Low Level Laser System i-lipo™ System Proprietary name

C. Predicate Devices:

Chromogenex Technologies Limited - ilipo Ultra System - K101366 Erchonia Medical Inc - Erchonia ML Scanner - K082609

D. Device Description:

ய் Intended Use:

The Chromogenex Technologies Limited i-lipo™ Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

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F. Comparison with the Predicate Devices:

The i-lipo is substantially equivalent to the predicates with respect to intended use and technological characteristics.

G. Clinical Testing

Randomised, blinded, placebo controlled circumferential reduction studies of the selected treatment area have been performed, which demonstrates the efficacy of the device, following 8 sessions of treatment each of 20 minutes duration, delivered 2 to 3 times per week over a 3 week period. After each treatment session, a 30-40 minute cardiovascular exercise was completed, based upon the participants existing exercise regimen. Exercise sessions ensure that released fatty acids and glycerol are utilised rather than restored back in the body.

H. Non Clinical Testing

Safety testing has been performed to EN 60950 for General Safety and, EN60601-2-22 and EN60825 standards for Medical Electrical Equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment. Electromagnetic compatibility has been tested to EN60601-2 - Medical Electrical Equipment - Part 1: General Requirements for Safety 2.

I. Conclusion

Based on the technological characteristics and clinical testing, the i-lipo™ is substantially equivalent to the above named predicate devices, for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of three wavy lines, resembling an abstract representation of a human form or a symbol of health and well-being.

Public Health Service

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

Chromogenex Technologies Limited % Mr. Peter R. Bevan Quality and Regulatory Manager Units1 and 2 Heol Rhosyn Parc Dafen Llanelli Carmarthenshire SA14 8QG

Re: K111501

Trade/Device Name: i-lipo™ System Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: II Product Code: OLI Dated: March 5, 2012 Received: March 7, 2012

Dear Mr. Bevan:

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.

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

MAR 2 3 2012

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Page 2 - Mr. Peter R. Bevan

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ton Duta

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Chromogenex Technologies Limited - i-lipo™ -Traditional 510(k) Application May 2011

Indications for Use

510(k) Number (if known): 11.150 1

Device Name: _ i-lipo™ System

Indications for use:

The i-lipo™ Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Neil R. Ryden for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111501

F01-1312_1__2

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.