(30 days)
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML capabilities. The software mentioned is for operational compliance, not for intelligent processing or decision-making.
No
The device is indicated for non-invasive dermatological aesthetic treatment for the reduction of body circumference, which is not a therapeutic purpose.
No
The device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference, which is a treatment, not a diagnostic purpose.
No
The device description clearly details hardware components, specifically laser diodes and adjustable laser arms, and describes the physical mechanism of action (emitting laser light). While software is mentioned as being incorporated, the device is fundamentally a hardware-based laser system.
Based on the provided text, the Erchonia Zerona® VZ8 is not an In Vitro Diagnostic (IVD) device.
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 interacts directly with the patient's body to emulsify adipose tissue. This is a physical treatment, not a diagnostic test.
- Lack of IVD Characteristics: The text 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 samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Zerona® VZ8 is clearly described as a therapeutic device for aesthetic purposes.
N/A
Intended Use / Indications for Use
The Erchonia Zerona® VZ8 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Product codes
OLI
Device Description
The Zerona® VZ8 laser is designed for clients seeking noninvasive circumference reduction without invasive surgery. Zerona® VZ8 allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® VZ8 works by emulsifying adipose tissue which then releases into the interstitial space. Zerona VZ8 was built on the clinical foundation of its predecessors, Violet ZERONA® Z6 and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Zerona® VZ8 is identical to the predecessor device, the Erchonia Violet ZERONA® Z6 OTC cleared under K231474, with the difference in the number of laser diodes (eight compared to six). The Installation and Proper Use Reference Guide for use for the Zerona® VZ8 is identical to the predecessor laser, the Erchonia® Violet ZERONA® Z6 OTC: consisting of the similar treatment set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Zerona® VZ8 emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the eight specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® VZ8 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 Zerona® VZ8 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 (21 CFR 801 Subpart C)
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 type, sample size, AUC, MRMC, standalone performance, key results)
No clinical study results are being submitted as part of this submission.
Safety and EMC testing was conducted on the Erchonia® Zerona® VZ8. The device complies with the IEC 60601-1, IEC 60601-1-2 and IEC 60825-1 standards.
All identified risks have been mitigated to ensure the lowest acceptable risk possible using the ISO 14971 standard framework.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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.
January 10, 2025
Erchonia Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K243811
Trade/Device Name: Erchonia Zerona® VZ8 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: December 11, 2024 Received: December 11, 2024
Dear Prithul Bom:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -> Date: 2025.01.10
12:00:56 -05 12:00:56 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243811
Device Name Erchonia Zerona® VZ8
Indications for Use (Describe)
The Erchonia Zerona® VZ8 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary K243811
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 112 Southchase Blvd. Fountain Inn, SC 29644 Telephone: 888-242-0571 Fax: 321-473-1608
Establishment Registration Number 2032513
Name and Address of Official Correspondent
Erchonia Corporation 112 Southchase Blvd. Fountain Inn, SC 29644 Contact: Travis Sammons Telephone: 888-242-0571 Fax: 321-473-1608 Email: tsammons@erchonia.com
Date Prepared
11/01/2024
Device Information
Trade Name: Erchonia Zerona® VZ8 Model#: VZ8 Common Name: Fat Reducing Low Level Laser Classification Name: Low level laser system for aesthetic use Requlation Description: 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
Primary Predicate Trade Name: Erchonia® Violet ZERONA® Z6 OTC 510K: K231474 Common Name: Fat Reducing Low Level Laser Classification Name: Low level laser system for aesthetic use. (21 CFR 878.5400) Product Code: OLI
Secondary Predicate
5
Trade Name: Erchonia® Emerald 510K: K192544 Common Name: Fat Reducing Low Level Laser Classification Name: Low level laser system for aesthetic use. (21 CFR 878.5400) Product Code: OLI
Device Description
The Zerona® VZ8 laser is designed for clients seeking noninvasive circumference reduction without invasive surgery. Zerona® VZ8 allows the patient to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® VZ8 works by emulsifying adipose tissue which then releases into the interstitial space. Zerona VZ8 was built on the clinical foundation of its predecessors, Violet ZERONA® Z6 and ZERONA® Z6 OTC, which were proven through clinical studies to be safe and effective in the application of circumference reduction.
The Zerona® VZ8 is identical to the predecessor device, the Erchonia Violet ZERONA® Z6 OTC cleared under K231474, with the difference in the number of laser diodes (eight compared to six). The Installation and Proper Use Reference Guide for use for the Zerona® VZ8 is identical to the predecessor laser, the Erchonia® Violet ZERONA® Z6 OTC: consisting of the similar treatment set-up and same treatment protocol involving 6 treatments occurring over 2 weeks: 3 treatments per week; each treatment every other day.
The Zerona® VZ8 emits a 405-nanometer wavelength with a tolerance of ±10 nanometer, from each of the eight specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® VZ8 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 Zerona® VZ8 complies with FDA and ISO Software Development and Validation regulations.
Intended Use
Zerona VZ8 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.
Zerona® VZ8 is intended to be distributed for Over-the-Counter (OTC) use.
Comparison of Technological Characteristics with the Predicate Device(s)
The Erchonia® Zerona® VZ8 is substantially equivalent to both its primary and secondary predicate devices. The primary predicate device, the Erchonia® Violet ZERONA® Z6 OTC (cleared under K231474), is the predecessor to the newly designed Zerona® VZ8 (subject device). Both devices share the same operational principles, including wavelength, power, energy source, and delivery method. The sole technological distinction between the subject and primary predicate device is the incorporation of two additional diode lasers, which does not compromise substantial equivalence, safety, or effectiveness, nor does it introduce new safety or effectiveness concerns. Additionally, the Erchonia® Zerona® VZ8 is substantially equivalent to the secondary predicate device, the Erchonia® Emerald. Both devices share an identical design, energy source, number of diodes, and total fluence.
6
| Device | Erchonia Zerona® VZ8 | Erchonia® Violet ZERONA®
Z6 OTC | Erchonia® Emerald |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | Unknown | K231474 | K192544 |
| | Subject Device | Primary Predicate | Secondary Predicate |
| Manufacturer | Erchonia | Erchonia | Erchonia |
| Device Design | Image: Erchonia Zerona VZ8 device | Image: Erchonia Violet ZERONA Z6 OTC device | Image: Erchonia Emerald device |
| Indication for
Use | The Zerona® VZ8 is indicated for use
as a non-invasive dermatological
aesthetic treatment for the reduction of
body circumference. | The Violet ZERONA Z6 OTC Laser is
indicated for use as a non-invasive
dermatological aesthetic treatment for the
reduction of body circumference. | Erchonia® Emerald (Model# SHL)
Laser is indicated for use as a non-
invasive dermatological aesthetic
treatment for the reduction of body
circumference in individuals with a
Body Mass Index (BMI) up to 40 kg/m2 |
| Laser Power | $23mW \pm 2mW$ | $23mW \pm 2mW$ | $16mW \pm 1.25mW$ |
| Wavelength | 400nm to 415nm | 400nm to 415nm | 522nm to 542 nm |
| Energy
Source | Multi diode collected then line
dispersed (coherent) | Multi diode collected then line dispersed
(coherent) | Multi diode collected then line
dispersed (coherent) |
| Number of
Laser Diodes | 8 | 6 | 10 |
| Energy
Delivery | Floor model device with probe head | Floor model device with probe head | Floor model device with probe head |
| Total
Treatment
Time Applied | 20 minutes | 20 minutes | 30 minutes |
| Total Fluency | 221 J | 165 J | 288 J |
| Target Size
Per Diode | Line pattern, electronically scanned
over area of treatment | Line pattern, electronically scanned over
area of treatment | Line pattern, electronically scanned
over area of treatment |
| User
Interface | LCD Touchscreen | LCD Touchscreen | LCD Touchscreen |
| Principles of
Operation | Mains power, converted to DC,
powering semi-conductor diodes | Mains power, converted to DC, powering
semi-conductor diodes | Mains power, converted to DC,
powering semi-conductor diodes |
| 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 | Low level light energy used as an
adjunct to emulsify adipose tissue |
| Product Code | OLI | OLI | OLI |
7
Performance Standards
The Erchonia® Zerona® VZ8 complies with FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).
Sterilization and Shelf-Life
The device is not provided sterile.
The device is not affected by shelf-life because it is an electro-mechanical device that is not sterile and whose components will not degrade over time while simply sitting in storage prior to initial use.
Performance Testing-Animal
No animal testing conducted
Performance Testing-Clinical
No clinical study results are being submitted as part of this submission
Risk Assessment
The Erchonia® Zerona® VZ8 is acceptable in accordance with IEC 60601 and IEC 60825, 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.
Performance Data
Safety and EMC testing was conducted on the Erchonia® Zerona® VZ8. The device complies with the IEC 60601-1, IEC 60601-1-2 and IEC 60825-1 standards.
Compliance with Voluntary Standards
The Erchonia® Zerona® VZ8 complies with the following voluntary standards: IEC 60601-1-2:2014+AMD1:2020 Edition 4.1 IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2 IEC 60825-1:2014 Edition 3.0
Substantially Equivalent Discussion
The Erchonia Zerona® VZ8 is substantially equivalent to its predecessor, the Erchonia® Violet ZERONA® Z6 OTC, cleared under K231474. Both devices share the same laser wavelength, power, energy source, and treatment duration. The sole technological distinction between the Zerona® VZ8 (subject device) and the Violet ZERONA® Z6 OTC (predicate device) is the incorporation of two additional laser diodes [8 vs 6], resulting in improved laser coverage of the treatment area. The safety and efficacy of employing additional laser diodes has been substantiated by the Erchonia Emerald (secondary predicate device), cleared under K192544. Sharing a comparable design with the subject device, the Erchonia Emerald was supported by safety and efficacy data from a full-scale controlled and powered clinical trial utilizing ten laser diodes compared to the subject device's eight. Moreover, the subject device's total fluence [221J] remains within the safety and efficacy parameters established by the secondary predicate [288J].
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 Zerona® VZ8 (subject device) is substantially equivalent to the Erchonia® Violet ZERONA® Z6 OTC (predicate device), indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.