The Vevazz LED can be used to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Device Description

The Vevazz is a non-invasive red-light system. The device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm; +/- 25 nm uniformly over the treatment area without producing hot spots. Treatment time is preset to 7 minutes for non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

AI/ML Overview

Acceptance Criteria and Study for Vevazz LED

This document outlines the acceptance criteria and the study conducted to demonstrate the Vevazz LED device's performance for the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Vevazz LED device was demonstrated through substantial equivalence to a predicate device, the Photonica Professional (K160880). The key performance metric was the "combined circumferential reduction of the waist, hips, and thighs" after a single treatment session.

Acceptance Criterion	Reported Device Performance (Vevazz LED)	Predicate Device Performance (Photonica Professional)
Substantial equivalence to predicate device in achieving combined circumferential reduction of waist, hips, and thighs.	Average combined circumferential reduction: 2.5 inches (from a single 28-minute treatment session) 100% of patients had clinically significant results, losing at least 1.0 inch. Breakdown by Gender: - Males (13 patients): 1 5/8 inches - Females (64 patients): 2 2/5 inches Breakdown by Study Site (average inch loss across 4 sites): - Site A (8 patients): 3 4/7 inches - Site B (16 patients): 1 2/3 inches - Site C (23 patients): 2 1/2 inches - Site D (30 patients): 2 1/6 inches Minimum inch loss observed: 1 inch Maximum inch loss observed: 7 1/2 inches	Average combined circumferential reduction: 3.5 inches (from one 32-minute treatment)
Treatment time	28 minutes (four 7-minute exposures)	32 minutes (four 8-minute treatments)
Safety: No device-related adverse events	No device-related adverse events were reported.	Not explicitly stated for predicate in provided text, but assumed to be safe as per FDA clearance.

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

Sample Size: 77 patients (64 female, 13 male)
Data Provenance: Retrospective analysis of existing treatment records from multiple private practice locations in the USA.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth measurements in the retrospective analysis. It notes that "measurements were taken in exact accordance with the Photonica Male Measurement Guide. Female Measurement Guide. Male Measurement Form, and Female Measurement Forms as were used in the clinical trials upon which the predication was approved." This suggests reliance on pre-established measurement protocols rather than independent expert adjudication for the retrospective data.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (such as 2+1, 3+1). The nature of the retrospective analysis of existing records suggests that measurements were likely taken by clinic staff following standardized protocols at the time of patient treatment, rather than an independent adjudication process for the study itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study was a retrospective analysis of the Vevazz LED's performance, with a direct comparison of its numerical results (average inch loss) to previously published results from the predicate device (Photonica Professional). It does not involve human readers evaluating cases with or without AI assistance.
Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as this was not an MRMC study comparing human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done in the sense that the Vevazz LED device itself (without direct human interpretive aid for results) was evaluated for its efficacy. The "performance" being measured is the physical effect of the device on patients (circumferential reduction), not an interpretation of images or data by an algorithm.

7. The Type of Ground Truth Used

Outcomes Data (Clinical Measurements): The ground truth was established by direct clinical measurements of circumferential reduction (in inches) of the waist, hips, and thighs taken before and immediately after treatment. These measurements were performed using self-tensioning tape measures and adhered to specific measurement guides established for the predicate device's clinical trials.

8. The Sample Size for the Training Set

The document describes a retrospective analysis of an existing device (Vevazz LED) to demonstrate its performance against a predicate. There is no mention of a "training set" in the context of machine learning or AI algorithms, as this is a physical medical device. The 77 patients' data constitutes the "test set" or clinical evidence for the device's efficacy.

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

Since there was no "training set" in the context of an AI/ML algorithm, this question is not applicable. The "ground truth" for the performance evaluation was established through direct pre- and post-treatment physical measurements of patients using standardized protocols.

Summary

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November 22, 2017 Vevazz, LLC Jamie Fettig Owner 3839 McKinney Ave. #251 Dallas, Texas 75204

Re: K172111

Trade/Device Name: Vevazz LED Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: July 10, 2017 Received: July 13, 2017

Dear Jamie Fettig:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S3 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) K172111

Device Name Vevazz LED

Indications for Use (Describe)

The Vevazz LED can be used to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 201.2 Subpart D)
☐ Over-The-Counter Use (21 CFR 201.2 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510-(k) Summary

1. Submitters Information

Name: Vevazz, LLC 3839 McKinney Ave. #251 DALLAS, TX 75204 Tel: 773-665-4005 Contact: Jamie Fettig, Owner 773-620-9500 jamie@healthyhuman.org

2. Date Prepared:

July 10, 2017

3. Device Name and Classification

Device	Vevazz LED
Trade Name	Vevazz LED
Regulation Description	Low Level Laser System for aesthetic use
Regulation Number	21 CFR 878.5400
Device Class	II
Review Panel	General and Plastic Surgery
Product Code	OLI

4. Intended Use

The Vevazz LED can be used to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

5. Device Description

Predicate Devices 6.

The Vevazz LED (K172111) is substantially equivalent to the following predicate device:

Photonica Professional (K160880) manufactured by Ward Photonics, LLC. ●

7. Substantial Equivalency Discussion

The intended use for this type of device (OLI) is equivalent to the predicate device, Photonica Professional by Ward Photonics. Both devices, the Vevazz (K172111) and Photonica Professional

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(K160880) cause lipolysis. which reduces the size of subcutaneous fat accumulations as a result of exposure to 650 nm red light. The Vevazz uses 650 nm ± 25 nm (visible red-light spectrum) which is the same red-light wavelength used by Photonica Professional.

The Vevazz is substantially equivalent to the predicate device and does not raise any new risks or hazards.

The principles of operation and base elements of the Vevazz LED device are very similar to the Photonica Professional predicate device in that the Vevazz LED and predicate device is fully compliant with USFDA recognized standards for electrical safety and emit a substantially equivalent amount of power and energy. Both the Vevazz LED and Photonica Professional devices achieve treatment area coverage through a soft uniform bath of red light. While the Photonica Professional uses an array of 150 diodes and a treatment time of 8 minutes, the Vevazz LED device uses an array of 8 or 16 LED light paddles placed about the treatment areas of the patient, each paddle consisting of 28 LED diodes for a treatment time of 7 minutes. As dosage is a mechanism of energy, coverage and time, the Vevazz LED has matched the effectiveness of the predicate with similar, more efficient method of treatment.

There are no differences between the subject device and the Photonica Professional with respect to indications and intended use. Any other differences where they occur are minor and do not represent any risk or hazard.

PerformanceCharacteristic	Submission DeviceVevazz	Predicate DevicePhotonicaProfessional
510K	K172111	K160880
Manufacturer	Vevazz LLC	Ward Photonics LLC
Date of FDAClearance	TBD	September 23, 2016
Intended Use	The Vevazz LED canbe used to provide thenon-invasivedermatologicalaesthetic treatment forthe reduction ofcircumference of hips,waist, and thighs.	PhotonicaProfessional isindicated for use as anon-invasivedermatologicalaesthetic treatment forthe reduction ofcircumference of hips,waist, and thighs.
Output (nominal)	120/240 VAC16 VDC	120 VAC
Power	50 mW/cm2	105 mW/cm2
Wavelength	650 nm +/- 25nm	635 nm +/-2nm
Waveform	Constant	Constant
Energy Source	Multi LED diodedispersed overtreatment area	Multi LED diodedispersed overtreatment area
Energy Delivery	Handheld TreatmentProbes (1-16 paddles)	LED array mounted onan articulated arm
Timer range	0-20 minutes	8 or 20 minutestreatment cycles
Treatment Time	7 minutes (default)	8 minutes or 20minutes
Software	None	None
Patient overridecontrol	Power off switch	Power off switch

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8. Non-Clinical Performance

The Vevazz is in compliance with the following standards listed below. The Vevazz has been tested for all designated tests, as applicable, given in the Guidance document: Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use (Document issued on: April 14, 2011). A detailed review of the performance and safety testing is given in Section: Performance Testing - Bench.

. IEC 60601-1:2005 +C1:2006, +C2:2007, AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-2-57:2011. Medical electrical equipment – Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

IEC 62471 Ed. 1, International Standard for Photobiological Safety for Lamps and Lamp Systems - General Requirements

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.

9. Clinical Performance Data:

A multi-site retrospective analysis has been performed on the records of 77 patients, which demonstrates the efficacy of the device using the Vevazz LED protocol with a 7-minute exposure to the front of the body. 7 minutes to the left side. 7 minutes to the back, and 7 minutes to the right side. with a total of 28 minutes exposure time for each treatment session.

The objective of this study is to retrospectively review existing treatment records at multiple private practice locations in the USA to determine the combined circumferential reduction of the waits, hips and thighs with a single 28 minute treatment session using the subject Vevazz LED product, without benefit of dieting or exercise, in order to establish a baseline of expected outcomes for patients who undertake this procedure and to compare the procedure's effectiveness with non-invasive fat reduction using the Photonica Professional fat reducing low level laser system by Ward Photonics LLC.

The studies differ in that the Ward Photonics LLC protocol was performed four 8-minute treatments.

In order to assure a fair comparison of the measurements with the predicate's measurement schema, the measurements in this study were taken in exact accordance with the Photonica Male Measurement Guide. Female Measurement Guide. Male Measurement Form, and Female Measurement Forms as were used in the clinical trials upon which the predication was approved. Those results were published in A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring.

The same self-tensioning tape measures were used for both studies. As detailed in the Photonica measurement quides and forms, multiple circumferential measurements were recorded for each patient. The measurement reference points are described in the Photonica Male Measurement Guide as quoted here for five measurements:

Back	Circumference at level of nipples
Upper-Abdomen	Distance above umbilicus
Mid-Abdomen	2-3 inches above the umbilicus
Flanks	Circumference around the "love handles"
Lower-Abdomen	Distance from umbilicus

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The measurement reference points are described in the Photonica Female Measurement Guide as quoted here for six measurements:

Back	Circumference where fat is under bra and notedistance in inches above the umbilicus
Waist	2-3 inches above umbilicus (note distance)
Mid-Abdomen	2-3 inches below the umbilicus (note distance)
Hips	Note distance below umbilicus
Thighs (right and left)	Greatest circumference, then note distance fromtop of kneecap.

The results of the retrospective analysis are summarized in the table below:

Title of Study:	A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring.
Study Objective	The objective of this study is to retrospectively review existing treatment records at multiple private practice locations in the USA to determine the combined circumferential reduction of the waist, hips, and thighs with a single 28 minute treatment session using the subject Vevazz LED product, without benefit of dieting or exercise, in order to establish a baseline of expected outcomes for patients who undertake this procedure and to compare the procedure's effectiveness with non-invasive fat reduction using Photonica Professional by Ward Photonics LLC
Number of Sites:	4
Enrollment Size:	77
Patient Population	For the study, 64 of the patients are female (83%) and 13 are male (17%). Females ranged in age from 18 to 77, with an average age of 41.7 years. Males ranged in age from 35 to 68, with an average age of 43.3 years. Overall, patients ranged in age from 18 to 77, with an average age of 42 years.
Study Design	Vevazz LED paddles were positioned directly over the skin with four 7-minute exposures. For males, the paddles were positioned:Front: Over the chest and abdomen, extending 23" toward suprapubic area. Back: Starting at the top of buttocks, extending 23 inches toward the upper back. Left: From the left hip area, extending 23 inches toward the left underarm area. Right: From the right hip area, extending 23 inches toward the right underarm area. For females, the paddles were positioned: Front: From below the bra and extending 23 inches to include the top of the thighs. Back: Covering the “back” measurement area and extending 23 inches to include the top of the thighs. Left: The paddles are placed to cover the left "love handle", the outside of the left thigh, and the inside of the right thigh

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• Right: The paddles are placed to cover the right "love handle", the outside of the right thigh, and the inside of the left thigh, along with the lower abdomen
Measurements and Timing	Measurements were taken immediately before and after the 28-minute treatment using a self-tensioning tape measure, measurement forms, and instructions (Measurement Guides) exactly as used in the clinical trials for the predicate Photonica Professional.Since measurements were taken immediately before and after the treatment, the observed results are therefore immediate.
Treatment	The treatments consist of four 7-minute exposures with the 650nm light positioned directly over the skin.Vevazz LED uses large paddles consisting of 28 LEDs in a series/parallel electrical connection. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm; +/- 25 nm uniformly over the treatment area.
Results	Inch loss by gender is:
	Gender	Patients	Age	Inch Loss	Std. Dev.
	Males	13	43.3	1 5/8	1 2/8
	Females	64	41.7	2 2/5	1 6/8
	Total	77	42.0	2 1/80	1 1/2
	Inch loss by treatment site is:
	Site	Patients	Age	Inch Loss	Std. Dev.
	A	8	49.1	3 4/7	1 2/8
	B	16	48.7	1 2/3	1 5/8
	C	23	40.7	2 1/2	2
	D	30	37.2	2 1/6	1 6/8
	Total	77	43.9	2 1/2	1 5/8
	Patients lost a minimum of 1". The maximum lost is 7 1/2".
	For males, inch loss is computed by adding the inch loss measurements for back, upper-abdomen, mid-abdomen, flanks and lower abdomen.
	For females, inch loss is computed by adding the inch loss measurements for back, waist, mid-abdomen, hips and thighs.
Adverse Events	There were no device-related adverse events
Substantially Equivalent to Predicate	Vevazz LED achieved an average combined circumferential reduction of the waits, hips, and thighs of 2.5" at one visit using the same measurements schema as in the Photonica Professional study which found an average loss of 3.5" with one 32-minute treatment

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Further, 100% of patients had clinically significant results at one visit with Vevazz LED, considering that all patients lost at least 1.0" with one treatment. By comparison, traditional liposuction is limited to removal of no more than 500 ml of fat at one surgery, due to the attendant trauma and potential sideeffects.

NOTE: While treatment with Vevazz LED immediately reduces the size of subcutaneous fat accumulations exposed to the lights, treatments do not prevent the patients from subsequently gaining weight or increasing the size of the fat accumulations.

The durability of the treatment has not been studied or established in follow-up clinical trials with a sufficiently statistically significant sample.

10. Conclusion

The Vevazz is substantially equivalent to the Photonica Professional manufactured by Ward Photonics (K160880).

The results of non-clinical performance data confirm that the Vevazz LED delivers substantially equivalent Total Treatment Dose of 650 nm ±25 light to the subcutaneous fat cells in 28 minutes at one visit rather than in 32 minutes at one visit.

The results of clinical testing confirm that the Vevazz LED achieves circumferential reduction substantially equivalent to the Photonica Professional, but in 28 minutes rather than 32 minutes.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for its intended use.

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.