(29 days)
Not Found
No
The description focuses on the laser technology and its physical effects, with no mention of AI or ML for data analysis, image processing, or treatment optimization.
No.
The device's stated "Intended Use / Indications for Use" is "as a non-invasive dermatological aesthetic treatment of body circumference," indicating an aesthetic purpose rather than a therapeutic one.
No
The device is indicated for use as a non-invasive dermatological aesthetic treatment of body circumference, which is a treatment, not a diagnostic purpose.
No
The device description clearly outlines hardware components such as laser diodes, lenses, adjustable arms, power cord, and power supply. It also describes the physical operation of the laser technology. While software is mentioned as being incorporated into the operation, the device is fundamentally a hardware-based laser system.
Based on the provided text, the Zerona® Z-Bed Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "as a non-invasive dermatological aesthetic treatment 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 any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or other materials for sample testing
The device is clearly described as a non-invasive treatment device for aesthetic purposes.
N/A
Intended Use / Indications for Use
The Zerona® Z-Bed Laser is indicated for use as a non-invasive dermatological aesthetic treatment of body circumference.
Product codes (comma separated list FDA assigned to the subject device)
OLI
Device Description
The Zerona® Z-Bed laser is specially designed for non-invasive fat loss. Zerona® Z-Bed is a new body-sculpting procedure designed for client's seeking noninvasive fat loss without invasive surgery. Zerona® Z-Bed allows the individual to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® Z-Bed works by utilizing proven low level laser technology to emulsify adipose tissue (defined as leakage of the fat out of the cell) which then releases into the interstitial space. The excess fat is passed through the body during its normal course of detoxification. The Zerona® Z-Bed was built on the clinical foundation of its predecessors, Zerona® Z6 OTC, Zerona® and Zerona®-AD which were proven through a double-blind, randomized, multi-site, and placebo controlled studies to be safe and effective in the application of circumference reduction and noninvasive fat loss.
The Zerona® Z-Bed emits a 635 nanometer wavelength with a tolerance of ±10 nanometer, from each of the twelve specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® Z-Bed 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 17.5mW (± 1.25mW) measured, per non-convergent beams. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas. In this position the diode emits a line width of 3mm and a mean length of 3.5in. (8.9cm), each line emits approximately (.0002 joules per cm² / minute) per area at 3inches and approximately (.0001 joules per cm2 / minute) per area at 4inches. The treatment time of 20 minutes would be approximately .004 /cm² at 3 inches and approximately .002 //cm² at 4 inches away from the skin.
The Zerona® Z-Bed laser device has been classified by the FDA/EC as a Class II/IIa device and a Class I/2 Laser. This designation represents a current standard for use in order to ensure the safety of the individual. A Class II/Ia Laser is determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and maintaining it there for an extended period of time could prove to be damaging.
The Zerona® Z-Bed laser device has been classified by the FDA Class II device and a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The performance parameters and intended use of the Erchonia® Zerona® Z-Bed are compliant to the internationally recognized safety testing standards for medical devices. The testing of the Zerona® Z-Bed device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 audits. The software incorporated into the operation of the Zerona® Z-Bed complies with FDA and ISO Software Development and Validation regulations.
The Zerona® Z-Bed laser package is comprised of (1) Zerona® Z-Bed Laser Device, (1) Laser Safety Glasses, (1) Power Cord, (1) Power Supply, (1) Tape Measure, (1) Pack of Disinfectant Wipes, and (1) Operation & Maintenance Manual. This following information is included to familiarize you with the components of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body circumference
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 24, 2022
Erchonia Corporation % Prithul Bom Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220519
Trade/Device Name: Erchonia Zerona Z-Bed Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use 878.5650 Regulatory Class: Class II Product Code: OLI Dated: February 22, 2022 Received: February 23, 2022
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 (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.
1
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) 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 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). 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.
Purva Pandya, D.Eng. 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
2
Indications for Use
510(k) Number (if known) K220519
Device Name Zerona® Z-Bed
Indications for Use (Describe)
The Zerona® Z-Bed Laser is indicated for use as a non-invasive dermatological aesthetic treatment 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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3
510(k) Summary K220519
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 Rd. 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
01/10/2022
Device Information
Trade Name: Erchonia Zerona® Z-Bed Model#: JZB 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
Trade Name: Zerona® Z6 OTC 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) Product Code: OLI
4
Device Description
The Zerona® Z-Bed laser is specially designed for non-invasive fat loss. Zerona® Z-Bed is a new body-sculpting procedure designed for client's seeking noninvasive fat loss without invasive surgery. Zerona® Z-Bed allows the individual to continue their daily activities without interruptions from surgery, pain, wounds or garments. The Zerona® Z-Bed works by utilizing proven low level laser technology to emulsify adipose tissue (defined as leakage of the fat out of the cell) which then releases into the interstitial space. The excess fat is passed through the body during its normal course of detoxification. The Zerona® Z-Bed was built on the clinical foundation of its predecessors, Zerona® Z6 OTC, Zerona® and Zerona®-AD which were proven through a double-blind, randomized, multi-site, and placebo controlled studies to be safe and effective in the application of circumference reduction and noninvasive fat loss.
The Zerona® Z-Bed emits a 635 nanometer wavelength with a tolerance of ±10 nanometer, from each of the twelve specially created and patented electronic diodes. Laser devices are typically constructed to emit a "spot" of light. The Zerona® Z-Bed 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 17.5mW (± 1.25mW) measured, per non-convergent beams. Laser diodes and adjustable laser arms are positioned no greater than 3-4 inches away from the client's target treatment areas. In this position the diode emits a line width of 3mm and a mean length of 3.5in. (8.9cm), each line emits approximately (.0002 joules per cm² / minute) per area at 3inches and approximately (.0001 joules per cm2 / minute) per area at 4inches. The treatment time of 20 minutes would be approximately .004 /cm² at 3 inches and approximately .002 //cm² at 4 inches away from the skin.
The Zerona® Z-Bed laser device has been classified by the FDA/EC as a Class II/IIa device and a Class I/2 Laser. This designation represents a current standard for use in order to ensure the safety of the individual. A Class II/Ia Laser is determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and maintaining it there for an extended period of time could prove to be damaging.
The Zerona® Z-Bed laser device has been classified by the FDA Class II device and a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The performance parameters and intended use of the Erchonia® Zerona® Z-Bed are compliant to the internationally recognized safety testing standards for medical devices. The testing of the Zerona® Z-Bed device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 audits. The software incorporated into the operation of the Zerona® Z-Bed complies with FDA and ISO Software Development and Validation regulations.
The Zerona® Z-Bed laser package is comprised of (1) Zerona® Z-Bed Laser Device, (1) Laser Safety Glasses, (1) Power Cord, (1) Power Supply, (1) Tape Measure, (1) Pack of Disinfectant Wipes, and (1) Operation & Maintenance Manual. This following information is included to familiarize you with the components of the device.
Indication for Use
The Zerona® Z-Bed Laser is indicated for use as a non-invasive dermatological aesthetic treatuction of body circumference.
Zerona® Z-Bed is intended to be distributed for Over-the-Counter (OTC) use.
5
Design Change
The principles of operation of the Erchonia® Zerona® Z-Bed (Model#JZB) are identical to the predicate device, Erchonia® Zerona® Z6 OTC (Model# SHR), with the exception of a design change. Below is a table that details the design changes of the technology between the Zerona® Z-Bed (subject device) and the Zerona® Z6 OTC (predicate device).
| Erchonia® Zerona® Z6 OTC
(Model# SHR) | Erchonia® Zerona® Z-BED
(Model# JZB) | Reason for Change |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: Erchonia® Zerona® Z6 OTC | Image: Erchonia® Zerona® Z-BED | Updated Appearance |
| Standalone laser platform to be
positioned over standard treatment
table ( not included ) | Incorporates a built-in user laying
surface | Eliminates the need for
independent treatment table |
| Device Total Laser Diodes: 6
laser diodes located in the main head
assembly. The main head assembly
with six laser diodes is applied to the
anterior, and once treatment is
complete, the individual rotates over,
and the main head assembly is applied
to the posterior. | Device Total Laser Diodes: 12
Six laser diodes located in the top
head assembly applied to the
anterior and six laser diodes located
underneath user laying surface
applied to the posterior. | The addition of six diodes
located underneath the user
laying surface allows for the
anterior and posterior of the
individual to be treated
simultaneously; and eliminates
the two-step treatment process,
involving the individual treating
anterior and then rotating over
for treatment of posterior. |
| Erchonia® Zerona Z6 OTC
(Model# SHR) | Erchonia® Zerona® Z-BED
(Model# JZB) | Areas Left Unchanged |
| Six laser diodes are applied to each
treatment surface area.
(anterior/ posterior)
20-minute treatment time per surface
area. (anterior/ posterior) | Six laser diodes are applied to each
treatment surface area.
(anterior/ posterior)
20-minute treatment time per
surface area. (anterior/ posterior) | The number of diodes applied
per treatment area (anterior/
posterior) remains at 6 diodes.
Treatment time per surface area
remains at 20 minutes. (anterior/
posterior) |
| Laser applicator heads: Line pattern,
electronically scanned over area of
treatment ( $516 cm^2$ ) | Laser applicator heads: Line pattern,
electronically scanned over area of
treatment ( $516 cm^2$ ) | Laser applicator heads remains a
line pattern, electronically
scanned over area of treatment
( $516 cm^2$ ) |
| The main arm adjustment is designed
using spring tension. The adjustment
of the main arm is by manual
movement from the end user. This
allows the end user to lower and raise
for proper positioning to individual for
accurate treatment distance. | The top head assembly adjustment
is designed using spring tension.
The adjustment of the top head
assembly is by manual movement
from the end user. This allows the
end user to lower and raise for
proper positioning to individual for
accurate treatment distance. | The top head assembly
adjustment remains the use of
spring tension for manual
movement from the end user. |
6
Performance Data
Compliance with Voluntary Standards
The Erchonia® Zerona® Z-Bed complies with the following voluntary standards: IEC 60601-1-2:2014 Edition 4.0 IEC 60601-1:2005, AMD1:2012 IEC 60825-1:2014 Edition 3.0
Performance Standards
The Erchonia® XLR8 Laser complies with FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).
Software
Software verification and validation testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern.
Risk Assessment
The Erchonia® Zerona® Z-Bed, Model#: JZB 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
Safety and EMC testing was conducted on the Erchonia® Zerona® Z-Bed, Model#: JZB device complies with the IEC 60601-1, IEC 60601-2 and IEC 60825-1 standards.
Performance Testing-Animal
No animal testing conducted
Performance Testing-Clinical
No clinical study results are being submitted as part of this submission.
7
Comparison of Technological Characteristics with the Predicate Device
The Erchonia® Zerona® Z-Bed (Model#JZB) is substantially equivalent to the predicate device, the Erchonia® Zerona® Z6 OTC (Model# SHR) previously cleared under K162578. The Zerona® Z6 OTC is the predecessor to the newly designed Zerona® Z-Bed (subject device), both devices have same the principles of operation, including wavelengths, power, energy source, and energy delivery.
| Device | Erchonia® Zerona® Z-Bed | Erchonia Zerona® Z6 OTC |
|---|---|---|
| Ref. 510(k) | Subject Device | K162578 |
| Indication for Use | The Erchonia® Z-BED Laser is indicated | |
| for use as a non-invasive dermatological | ||
| aesthetic treatment for the reduction of | ||
| body circumference. | ||
| Erchonia® Z-BED is intended to be | ||
| distributed for Over-the-Counter (OTC) | ||
| use. | The ZERONA Z6 OTC Laser is indicated for | |
| use as a non-invasive dermatological aesthetic | ||
| treatment for the reduction of body | ||
| circumference. | ||
| Zerona® Z6 OTC is intended to be distributed | ||
| for Over-the-Counter (OTC) use. | ||
| Laser Power | 17.25mW ± 1.25mW | 17.25mW ± 1.25mW |
| Wavelength | Red 630 nm - 640 nm | Red 630 nm - 640 nm |
| Waveform | Constant Wave | Constant Wave |
| Energy Source | Multi diode collected then line dispersed | |
| (coherent) | Multi diode collected then line dispersed | |
| (coherent) | ||
| Power Supply | 100 - 240V~ 1.5-.5A, 50-60 Hz electrical | |
| outlet | 100 - 240V~ 1.5-.5A, 50-60 Hz electrical | |
| outlet | ||
| Number of Laser Diodes | ||
| Applied Per Treatment | ||
| Area | 6 | 6 |
| Energy Delivery | Floor model device with probe head | Floor model device with probe head |
| Treatment Time Applied | ||
| Per Area | 20 minutes | 20 minutes |
| Treatment Frequency | 3 x week, 2 weeks | 3 x week, 2 weeks |
| Total Fluency | 248 J | 248 J |
| Target Size Per Diode | Line pattern, electronically scanned over | |
| area of treatment (516 cm²) | Line pattern, electronically scanned over area | |
| of treatment (516 cm²) | ||
| User Interface | 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 | ||
| 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 | ||
| Product Code | OLI | OLI |
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Conclusion
The Erchonia® Zerona® Z-BED (Model# JZB) is substantially equivalent to the Erchonia® Zerona® Z6 OTC (Model# SHR), cleared under K162578. The design change does not render the device not substantially equivalent, does not affect the safety or effectiveness, or raise different questions of safety and effectiveness.
The only technological difference between the Zerona® Z-BED (subject device) and Zerona® Z6 OTC (predecessor device) is the addition of six laser diodes, which provides the means to administer the treatment to the anterior and posterior of the individual simultaneously and therefore eliminating the two-step treatment process, involving the individual treating anterior and then rotating over for treatment of posterior. This change does not affect the safety or effectiveness due to the Zerona® Z-BED (subject device) and Zerona® Z6 OTC (predecessor device) deliver the same number of diodes (6), laser power (17.25mW) and treatment time (20 minutes) to each treatment area (anterior/ posterior). Furthermore, both the subject device and predecessor deliver the same amount of total light energy (248 J).
Therefore, we conclude that the Erchonia® Zerona® Z-BED redesign (subject device) is substantially equivalent to the predecessor, Erchonia Zerona® Z6 OTC (predicate device), indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference