(60 days)
No
The summary describes a laser device for circumference reduction and mentions standard software compliance, but there is no indication of AI or ML being used for analysis, decision-making, or image processing.
No
The device is indicated for non-invasive dermatological aesthetic treatment for the reduction of body circumference, which is primarily a cosmetic rather than a therapeutic indication.
No
The device is intended for non-invasive dermatological aesthetic treatment for the reduction of body circumference, not for diagnosing medical conditions.
No
The device description explicitly states it is a "laser" and describes physical components like "electronic diodes," "proprietary patented lens," "line refractor," and "laser applicator heads," indicating it is a hardware device that utilizes software for operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a non-invasive dermatological aesthetic treatment for the reduction of body circumference." This describes a treatment applied to the body, not a test performed on samples taken from the body.
- Device Description: The description details a laser device that emits light to affect adipose tissue within the body. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly intended for external application to the body for aesthetic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Product codes
OLI
Device Description
The Violet ZERONA® Z6 OTC laser is designed for client's seeking noninvasive circumference reduction without invasive surgery. Violet ZERONA® Z6 OTC allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Violet ZERONA® Z6 OTC works by emulsifying adipose tissue which then releases into the interstitial space. The Violet ZERONA® Z6 was built on the clinical foundation of its predecessors, Zerona® and Zerona®-AD, and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Erchonia Violet ZERONA® Z6 OTC is identical to the predecessor device, the Erchonia ZERONA® Z6 OTC cleared under K162578, with the differences being light output (visible violet compared to visible red) and duration of treatment administrations (20 minutes compared to 40 minutes, which is automatically programmed into the device). The Installation and Proper Use Reference Guide for use for the Erchonia® Violet ZERONA® Z6 OTC are identical to those for use of the predecessor laser, the Erchonia® ZERONA® Z6 OTC; consisting of the same device set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Violet ZERONA® Z6 OTC emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the six specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Violet ZERONA® Z6 OTC laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.
The software incorporated into the operation of the Violet ZERONA® Z6 OTC complies with FDA and ISO Software Development and Validation regulations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
Not Found
Summary of Performance Studies
STUDY DESIGN: This clinical study was an open-label single-arm design to evaluate the efficacy of application of the Erchonia Violet ZERONA® Z6 OTC violet laser application to that of application of the Erchonia® ZERONA Z6 OTC red laser for the reduction of body circumference.
SUBJECTS: Twenty-five (25) subjects, 84% of whom were female completed the study. Mean subject age was 49.96 years, mean baseline body mass index (BMI) was 26.43kg/m², and mean baseline combined waist-hips-bilateral thighs circumference was 123.16.
STUDY PROCEDURES: Each subject received six (6) treatments with the Erchonia Violet ZERONA® Z6 OTC across a two-week period. The study procedure was identical to that evaluated in the comparative study, with the difference being evaluated in this study being use of a violet rather than red laser and a reduction in per-treatment administration time from 40 minutes to 20 minutes.
STUDY MEASURES: The study primary outcome measure of combined waist-hips-bilateral thighs circumference (inches) was measured at baseline and at completion of the two-week treatment phase (study endpoint).
STUDY RESULTS: Success for the current study group was pre-determined as mean change in combined circumference measurements of -3.72±5% inches (-3.53 to -3.91 inches). The mean change in total body circumference measurement at study endpoint relative to baseline was -3.91 inches, falling within the prespecified maximally clinically acceptable difference range (-3.53 to -3.91 inches), and exceeding the preestablished lower boundary of -3.53 inches; thereby establishing study primary success.
SAFETY: No adverse events were reported or observed for any subject across study duration.
CONCLUSION: The study results demonstrate that application of the Erchonia Violet ZERONA® Z6 OTC violet laser is as effective in providing clinically meaningful circumference reduction as the Erchonia ZERONA® Z6 OTC red laser, with half the required per-treatment administration time (from 40 to 20 minutes), which is a significant time savings to the patient.
Key Metrics
Mean change in total body circumference measurement at study endpoint relative to baseline was -3.91 inches.
Combined Circumference Reduction (inches) for Erchonia Violet ZERONA® Z6 OTC: 3.91 (95% CI: 3.26 - 4.56).
Side Effects for Erchonia Violet ZERONA® Z6 OTC: None.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
July 21, 2023
Erchonia Corporation Travis Sammons Clinical Affairs Manager 650 Atlantis Rd. Melbourne, Florida 32904
Re: K231474
Trade/Device Name: Erchonia Violet ZERONA® Z6 OTC Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: May 18, 2023 Received: May 22, 2023
Dear Travis Sammons:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231474
Device Name Violet ZERONA® Z6 OTC
Indications for Use (Describe)
The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K231474
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Owner Information Name and Address of Sponsor / Manufacturer
Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 Telephone: 321-473-1251 Fax: 321-473-1608
Establishment Registration Number
2032513
Name and Address of Official Correspondent
Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 Contact: Travis Sammons Telephone: 321-473-1251 Fax: 321-473-1608 Email: tsammons@erchonia.com
Date Prepared
7/21/2023
Device Information
Trade Name: Erchonia Violet ZERONA® Z6 OTC Model#: VZ6 Common Name: Fat Reducing Low Level Laser Classification Name: 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. (21 CFR 878.5400) Classification: Class II Panel: General & Plastic Surgery Product Code: OLI
Predicate Device
Erchonia ZERONA® Z6 OTC previously cleared under K162578.
Reference Device
Erchonia Zerona® Z6 OTC cleared under K143007.
The procedure administration protocol performed with the subject device, Erchonia Violet ZERONA® Z6 OTC, is identical to that evaluated in the comparative study which supported 510(k) clearance for K143007, with the difference in this current study being the use of a violet rather than red laser and a reduction in per-treatment administration time from 40 minutes to 20 minutes. Both the subject and reference devices administered the same treatment protocol of 6 treatments occurring over 2 weeks.
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Device Description
The Violet ZERONA® Z6 OTC laser is designed for client's seeking noninvasive circumference reduction without invasive surgery. Violet ZERONA® Z6 OTC allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Violet ZERONA® Z6 OTC works by emulsifying adipose tissue which then releases into the interstitial space. The Violet ZERONA® Z6 was built on the clinical foundation of its predecessors, Zerona® and Zerona®-AD, and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Erchonia Violet ZERONA® Z6 OTC is identical to the predecessor device, the Erchonia ZERONA® Z6 OTC cleared under K162578, with the differences being light output (visible violet compared to visible red) and duration of treatment administrations (20 minutes compared to 40 minutes, which is automatically programmed into the device). The Installation and Proper Use Reference Guide for use for the Erchonia® Violet ZERONA® Z6 OTC are identical to those for use of the predecessor laser, the Erchonia® ZERONA® Z6 OTC; consisting of the same device set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Violet ZERONA® Z6 OTC emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the six specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Violet ZERONA® Z6 OTC laser utilizes internal mechanics that collects the light emitted from the laser diode and processes it through a proprietary patented lens, and then redirects the beam with a line refractor. The laser applicator heads, each produce an output power of 23mW (± 2mW) measured. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas.
The software incorporated into the operation of the Violet ZERONA® Z6 OTC complies with FDA and ISO Software Development and Validation regulations.
Intended Use
The Violet ZERONA® Z6 OTC is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Violet ZERONA® Z6 OTC is intended to be distributed for Over-the-Counter (OTC) use.
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Comparison of Technological Characteristics with the Predicate Device
The following table compares the subject device (Erchonia Violet ZERONA® Z6 OTC) to the predicate device (Erchonia ZERONA® Z6 OTC). The comparison provides detailed information regarding the basis for the determination of substantial equivalence.
| Device | Erchonia Violet ZERONA® Z6 OTC | Erchonia ZERONA® Z6 OTC | |
|---|---|---|---|
| 510(k) # | N/A | K162578 | Differences |
| Subject Device | Predicate Device | ||
| Device Design | Image: Erchonia Violet ZERONA® Z6 OTC | Image: Erchonia ZERONA® Z6 OTC | None |
| Indication for | |||
| Use | The Violet ZERONA Z6 OTC Laser is indicated | ||
| for use as a non-invasive dermatological aesthetic | |||
| treatment for the reduction of body | |||
| circumference. | The ZERONA Z6 OTC Laser is indicated for use | ||
| as a non-invasive dermatological aesthetic | |||
| treatment for the reduction of body | |||
| circumference. | None | ||
| Laser Power | $23mW \pm 2mW$ | $17.25mW \pm 1.25mW$ | Clinical study completed |
| (refer to Performance Testing | |||
| -Clinical) | |||
| Wavelength | Violet: 400nm- 415nm | Red: 630nm – 640nm | Clinical study completed |
| (refer to Performance Testing | |||
| -Clinical) | |||
| Energy Source | Multi diode collected then line dispersed | ||
| (coherent) | Multi diode collected then line dispersed | ||
| (coherent) | None | ||
| Number of | |||
| Laser Diodes | |||
| Applied Per | |||
| Treatment Area | 6 | 6 | None |
| Energy Delivery | Floor model device with probe head | Floor model device with probe head | None |
| Total | |||
| Treatment | |||
| Time Applied | 20 minutes | 40 minutes | Clinical study completed |
| (refer to Performance Testing | |||
| -Clinical) | |||
| Treatment | |||
| Frequency | 3 x week, 2 weeks | 3 x week, 2 weeks | None |
| Total Fluency | 165 J | 248 J | Clinical study completed |
| (refer to Performance Testing | |||
| -Clinical) | |||
| Target Size Per | |||
| Diode | Line pattern, electronically scanned over area of | ||
| treatment (516 cm²) | Line pattern, electronically scanned over area of | ||
| treatment (516 cm²) | None | ||
| User Interface | LCD Touchscreen | LCD Touchscreen | None |
| Principles of | |||
| Operation | Mains power, converted to DC, powering semi- | ||
| conductor diodes | Mains power, converted to DC, powering semi- | ||
| conductor diodes | None | ||
| Mechanism of | |||
| Action | Low level light energy used as an adjunct to | ||
| emulsify adipose tissue | Low level light energy used as an adjunct to | ||
| emulsify adipose tissue | None | ||
| Product Code | OLI | OLI | None |
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Performance Standards
The Erchonia Violet ZERONA® Z6 OTC complies with FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).
Risk Assessment
The Erchonia Violet ZERONA® Z6 OTC is acceptable in accordance with IEC 60601 edition 3.1. by virtue of Engineering and third-party verification. All identified risks have been mitigated to ensure the lowest acceptable risk possible using the ISO 14971 standard framework.
Electromagnetic Compatibility and Electrical Safety
The Erchonia Violet ZERONA® Z6 OTC utilizes the same components as the predicate device, Erchonia ZERONA® Z6 OTC, with the exception of the laser diode. The Erchonia Violet ZERONA® Z6 OTC emits violet light and the Erchonia ZERONA® Z6 OTC emits red light, the change does not alter the safety and EMC testing previously conducted on the Erchonia ZERONA® Z6 OTC. Therefore, the safety and EMC testing which was conducted on the Erchonia ZERONA® Z6 OTC device applies to the Erchonia Violet ZERONA® Z6 OTC. The device testing complies with the current IEC 60601-1, IEC 60601-2 and IEC 60825-1 standards.
Compliance with Voluntary Standards
The Erchonia Violet ZERONA® Z6 OTC complies with the following voluntary standards: IEC 60601-1-2:2014 Edition 4.0 IEC 60601-1:2005 Edition 3.1 IEC 60825-1:2014 Edition 3.0
Performance Testing-Clinical
BACK GROUND: The purpose of this clinical study was to determine the effectiveness of the Erchonia Violet ZERONA® Z6 OTC laser device, in providing noninvasive body circumference reduction.
STUDY DESIGN: This clinical study was an open-label single-arm design to evaluate the efficacy of application of the Erchonia Violet ZERONA® Z6 OTC violet laser application to that of application of the Erchonia® ZERONA Z6 OTC red laser for the reduction of body circumference.
SUBJECTS: Twenty-five (25) subjects, 84% of whom were female completed the study. Mean subject age was 49.96 years, mean baseline body mass index (BMI) was 26.43kg/m², and mean baseline combined waist-hips-bilateral thighs circumference was 123.16.
STUDY PROCEDURES: Each subject received six (6) treatments with the Erchonia Violet ZERONA® Z6 OTC across a two-week period. The study procedure was identical to that evaluated in the comparative study, with the difference being evaluated in this study being use of a violet rather than red laser and a reduction in per-treatment administration time from 40 minutes to 20 minutes.
STUDY MEASURES: The study primary outcome measure of combined waist-hips-bilateral thighs circumference (inches) was measured at baseline and at completion of the two-week treatment phase (study endpoint).
STUDY RESULTS: Success for the current study group was pre-determined as mean change in combined circumference measurements of -3.72±5% inches (-3.53 to -3.91 inches). The mean change in total body circumference measurement at study endpoint relative to baseline was -3.91 inches, falling within the prespecified maximally clinically acceptable difference range (-3.53 to -3.91 inches), and exceeding the preestablished lower boundary of -3.53 inches; thereby establishing study primary success.
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SAFETY: No adverse events were reported or observed for any subject across study duration.
CONCLUSION: The study results demonstrate that application of the Erchonia Violet ZERONA® Z6 OTC violet laser is as effective in providing clinically meaningful circumference reduction as the Erchonia ZERONA® Z6 OTC red laser, with half the required per-treatment administration time (from 40 to 20 minutes), which is a significant time savings to the patient.
Substantially Equivalent Discussion
The Erchonia Violet ZERONA® Z6 OTC is substantially equivalent to the predicate device, the Erchonia ZERONA® Z6 OTC previously submitted under K162578. Both the subject device and the predicate device have identical device design, number of diodes, energy delivery, treatment frequency, and mechanism of action. The differences in laser diodes (wavelength and laser power) and treatment time applied per area, is justified in the outcome of the clinical study that demonstrates the difference does not render the device not substantially equivalent, does not affect the safety or effectiveness, or raise different questions of safety and effectiveness.
The clinical data provided in this submission demonstrates that the application of the Erchonia Violet ZERONA® Z6 OTC (violet laser) maintains the same safety profile and is as effective in providing clinically meaningful circumference reduction as the Erchonia ZERONA® Z6 OTC (red laser), with half the required per-treatment administration time, which is a significant time savings to the patient. (See Table 1)
| | Erchonia Violet
ZERONA® Z6 OTC | Erchonia ZERONA® Z6
OTC |
|----------------------------------------------|-----------------------------------|----------------------------|
| Laser Diode | Violet | Red |
| n | 25 | 22 |
| Total Treatment Time Applied | 20 minutes | 40 minutes |
| Combined Circumference
Reduction (inches) | 3.91 (95% CI: 3.26 - 4.56) | 3.72 (95% CI: 2.78 – 4.66) |
| Side Effects | None | None |
Table 1: Combined Circumference Reduction Across Study Duration by Device
Conclusion
Any differences between the subject device and predicate do not render the device not substantially equivalent, do not affect safety or effectiveness, or raise different questions of safety and effectiveness. Therefore, the Erchonia Violet ZERONA® Z6 OTC (subject device) is substantially equivalent to the Erchonia ZERONA® Z6 OTC (predicate device), indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.