(132 days)
Not Found
No
The summary describes a red-light system with preset treatment times and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs, which is a therapeutic purpose.
No
The device is described as providing non-invasive dermatological aesthetic treatment for circumference reduction, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a base unit, LED paddles, power connections, and fuses, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs." This describes a therapeutic or aesthetic treatment applied directly to the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a light-emitting system applied externally. It doesn't mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic or monitoring purposes.
- Use in a laboratory setting for testing samples.
The Vevazz LED is clearly described as a device for external aesthetic treatment using light energy.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, waist, thighs
Indicated Patient Age Range
from 18 to 77
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Description of the test set: Patients who underwent treatment using the Vevazz LED protocol with circumferential measurements taken immediately before and after the 28-minute treatment.
Sample size: 77 patients (64 female, 13 male)
Data source: Records at multiple private practice locations in the USA.
Annotation protocol: Measurements were taken in exact accordance with the Photonica Male Measurement Guide and Female Measurement Guide using self-tensioning tape measures. Multiple circumferential measurements were recorded for each patient based on specific reference points (e.g., at level of nipples, distance above/below umbilicus, circumference around "love handles", greatest circumference of thighs).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Multi-site retrospective analysis
Sample size: 77 patients
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
- Average combined circumferential reduction of hips, waist, and thighs was 2.5 inches.
- Males: average inch loss of 1 5/8 inches.
- Females: average inch loss of 2 2/5 inches.
- All 77 patients lost at least 1.0 inch.
- Maximum inch loss observed was 7 1/2 inches.
- No device-related adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Inch Loss:
- Males: 1 5/8 inches avg.
- Females: 2 2/5 inches avg.
- Total: 2 1/80 inches avg.
- Minimum lost: 1.0 inch
- Maximum lost: 7 1/2 inches
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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):
1
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
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.
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.
| Performance
Characteristic | Submission Device
Vevazz | Predicate Device
Photonica
Professional |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K172111 | K160880 |
| Manufacturer | Vevazz LLC | Ward Photonics LLC |
| Date of FDA
Clearance | TBD | September 23, 2016 |
| 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. | Photonica
Professional is
indicated for use as a
non-invasive
dermatological
aesthetic treatment for
the reduction of
circumference of hips,
waist, and thighs. |
| Output (nominal) | 120/240 VAC
16 VDC | 120 VAC |
| Power | 50 mW/cm2 | 105 mW/cm2 |
| Wavelength | 650 nm +/- 25nm | 635 nm +/-2nm |
| Waveform | Constant | Constant |
| Energy Source | Multi LED diode
dispersed over
treatment area | Multi LED diode
dispersed over
treatment area |
| Energy Delivery | Handheld Treatment
Probes (1-16 paddles) | LED array mounted on
an articulated arm |
| Timer range | 0-20 minutes | 8 or 20 minutes
treatment cycles |
| Treatment Time | 7 minutes (default) | 8 minutes or 20
minutes |
| Software | None | None |
| Patient override
control | 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 note
distance 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 from
top 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.