The Lipofina Laser System (Figure 1) consists of a main console and 8 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 12 laser emission diode sources at a power output of 35mW per laser diode. These treatment paddles are non-thermal and noninvasive, at a wavelength of 658 (central).

AI/ML Overview

The provided document is a 510(k) summary for the Lipofina Laser System, which is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist. The document details a clinical study conducted to demonstrate the device's safety and effectiveness.

Here's an analysis of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Lipofina Laser System)
Primary Efficacy Endpoint: Achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final visit.	95% of subjects treated with the Lipofina Laser System lost at least 1 inch in their waistline.
Safety Endpoint: No device-related Adverse Events (AEs) or skin color changes.	No device-related AEs or skin color changes were reported for any subject.

2. Sample Size and Data Provenance

Sample Size (Test Set):
- Lipofina Laser System treated group: 20 subjects
- Control (sham) device group: 21 subjects
Data Provenance: The study was "at the request of CDRH," implying it was conducted as part of the FDA regulatory process. The geographical origin of the data (country) is not explicitly stated, but the sponsor, YOLO Medical Inc., is located in British Columbia, Canada, and the submission correspondent Rockin' Regulatory, Inc. is in California, USA, suggesting a North American context. The study was prospective as it was a "randomized, double blind clinical study."

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of medical image interpretation (e.g., radiologists reviewing images). The ground truth here is directly measured waistline circumference loss and observed adverse events.

4. Adjudication Method for the Test Set

Not applicable in the context of this study. The "ground truth" was objective measurement (waistline circumference) and direct observation for adverse events.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves multiple human readers evaluating medical images or data, with and without AI assistance, to assess the impact of AI on diagnostic accuracy or efficiency. The Lipofina Laser System is a physical device used for aesthetic treatment, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's effect was directly measured on subjects without human intervention in the treatment application that would alter the device's output. The clinical study was a randomized, double-blind trial demonstrating the device's efficacy on its own when applied as intended.

7. Type of Ground Truth Used

The ground truth used was objective measurement (waistline circumference loss) and clinical observation (for adverse events and skin color changes).

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The Lipofina Laser System is a low-level laser system, not an AI/ML-based device that would typically have a training set. The clinical study described served as the primary validation set to demonstrate the device's safety and efficacy.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention or indication of an AI/ML training set for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

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

April 24, 2015

YOLO Medical Incorporated % Mr. Paul Kramsky Rockin' Regulatory Incorporated 21831 Tumbleweed Circle Lake Forest, California 92630

Re: K143741

Trade/Device Name: Lipofina Laser System Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: April 3, 2015 Received: April 6, 2015

Dear Mr. Kramsky:

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 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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143741

Device Name Lipofina Laser System

Indications for Use (Describe)

The Lipofina Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for YOLO Medical Inc. The logo features the word "YOLO" in a stylized font, with the words "MEDICAL INC." in smaller font to the right. Below the word "YOLO" is the phrase "CHANGE. IT STARTS HERE" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name and tagline.

5.0 – 510(k) Summary for the Lipofina Laser System

5.1 Submission Sponsor:

YOLO Medical Inc. #245 - 1959 152"d Street Surrey, British Columbia V4A 9E3 CANADA Telephone: 604-542-2200 Fax: 604-542-2205 FDA Establishment Registration #: TBD

5.2 Submission Correspondent:

Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630 Telephone: 949-636-1464 Contact: Paul Kramsky, President Email: pkramsky@cox.net

5.3 Date Prepared:

December 29, 2014

5.4 Device Name:

Trade/Proprietary Name:	Lipofina Laser System
Common Name:	Low Level laser System (revised)
Classification Name:	Low Level Laser System for Aesthetic Use
Product Code:	OLI
Regulation Number:	878.5400
Device Class	II Special Controls
Review Panel:	General and Plastic Surgery

CONFIDENTIAL

Section 5.0

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Image /page/4/Picture/0 description: The image shows the logo for YOLO Medical Inc. The logo features the word "YOLO" in a stylized font, with the "O"s appearing as incomplete circles. To the right of "YOLO" is the text "MEDICAL INC." in a smaller, sans-serif font. Below the main logo is the tagline "CHANGE. IT STARTS HERE" in a simple, sans-serif font.

5.5 Substantial Equivalence:

The Lipofina Laser System is substantially equivalent in terms of both intended use and technological characteristics to the i-Lipo™ System, which was cleared for marketing under K111501 on March 23, 2012) for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist. The results of clinical testing, summarized in section 18.0 of this 510(k), confirm that the technological differences between the Lipofina and i-Lipo laser systems do not raise new issues of safety and effectiveness.

5.6 Device Description:

5.7 Indications for Use:

The Lipofina Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.

Performance Data: 5.8

Performance testing demonstrated the safety of the Lipofina Laser System in performing the waist reduction treatments. In addition, the Lipofina Laser System was tested and demonstrated to be in compliance with the IEC 60825 standard for Medical Electrical Equipment – Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment, IEC 60601-2-22, Medical Electrical Equipment (3td Edition, 2007-05), Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, IEC 60601-1, 30 Edition, Medical electrical equipment Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2 --Electromagnetic Compatibility (EMC), (2nd Edition, 2001) – Part 1: General Requirements for Safety; Electromagnetic compatibility.

CONFIDENTIAL

Section 5.0

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Image /page/5/Picture/1 description: The image shows the logo for YOLO Medical INC. The logo has the word "YOLO" in a stylized font, with the tagline "CHANGE. IT STARTS HERE" underneath. To the right of "YOLO" is the text "MEDICAL INC." in a smaller, sans-serif font. The overall design is clean and modern.

5.9 Clinical Testing:

At the request of CDRH, a randomized, double blind clinical study was conducted in which 20 subjects were treated with the Lipofina Laser System and 21 subjects received the control (sham) device. The YOLO TOUCH LLLT successfully met the primary efficacy endpoint of this study, which was the achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final visit, with 95% of subjects receiving treatment with the YOLO TOUCH LLLT device losing at least 1 inch in their waistline compared with 0 subjects in the arm receiving treatment with the sham device. In addition, no device-related AEs or skin color changes were reported for any subject during the course of this study. Taken together, these data demonstrate that the YOLO TOUCH LLLT device safely and successfully reduces waistline circumference after a course of nine 20-minute treatments in a 3-week period.

CONFIDENTIAL

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.