Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology, hardware components, and basic software for controlling the device's operation. There is no mention of AI or ML capabilities for data analysis, decision-making, or adaptive treatment.

Therapeutic

Yes
The device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference, which constitutes a therapeutic application aiming to alter a body function or structure.

Diagnostic

No

The device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference, which is a therapeutic rather than diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components including laser diodes, a mobile base, a touch screen, a PCB, and adjustable arms, indicating it is a physical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 directly to the patient's body, not a test performed on samples taken from the body.
Device Description: The description details a laser system that emits light onto the patient's skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic device that analyzes biological samples.
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 based on sample analysis.

The device is clearly described as a laser system for external application to the body for aesthetic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 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.

Product codes

OLI

Device Description

The Erchonia® Emerald (Model#: SHL) is low-level laser system that uses ten (10) semi-conductor diodes (visible green-light) 522nm to 542nm. The Erchonia® Emerald (Model#: SHL) has been classified by the FDA as a Class II device and a Class II Laser in accordance with IEC 60825-1 (Complies with 21 CFR 1040.10 and 21 CFR 1040.11 by laser notice #50. The performance parameters and intended use of the Erchonia® Emerald (Model#: SHL) are compliant to the internationally recognized safety testing standards for medical devices. The Erchonia® Emerald (Model#: SHL) device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 and MDSAP audits. The software incorporated into the operation of the Erchonia® Emerald (Model#: SHL) complies with FDA and ISO Software Development and Validation regulations.

The components of the device include a mobile base that plugs into the wall, using a hospital grade power cord, equipped with a medical-grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to mains power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end-user to alter the laser diode output. The protocol is factory set and cannot be altered by the end-user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the laser head assembly that is attached to the adjustable main arm utilizes internal mechanics that collects the light emitted from each of the ten (10) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly can be manually adjusted for positioning the lasers 3-4 inches from the patient's skin to deliver treatment for body contouring. The device laser head assembly can be moved vertically (raised or lowered) over the subject for proper height placement of lasers for treatment. The device laser head assembly can be moved horizontally (left or right) over the patient for proper placement of lasers for treatment. The device laser head assembly has two adjustable outside laser arms with each arm housing two (2) laser diodes that can be moved in and out for proper positioning to the patient for accurate treatment distance.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI), and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

Device Accessories:

Laser safety glasses (1) Patient & (1) Operator -
-Tape measure
Manual -
Power cord -

Assembly Accessories:

Large Screws (2) -
-1/8 (Large) Allen Driver
-Small Screws (4)
1/16 (Small) Allen Driver -
-Wire Cover
Arm Cover -

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

body circumference, hips, waist, upper abdomen, thighs

Indicated Patient Age Range

Not Found

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

Not Found

Summary of Performance Studies

Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237.
Key results: "the physiological mechanism of action provided by the Erchonia Corporation 532nm diode laser has demonstrated safety and effectiveness to support the proposed indication of use "as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) of up to 40 kg/m²."

Key Metrics

Not Found

Predicate Device(s)

K142042, K123237

Reference Device(s)

K162578

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Summary

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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Erchonia Corporation Mr. Steven Shanks President 650 Atlantis Road Melbourne, Florida 32904

Re: K192544

Trade/Device Name: Erchonia Emerald Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: September 13, 2019 Received: September 16, 2019

Dear Steven Shanks:

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 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

1

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,

Jessica Mavadia-Shukla Acting 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

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Indications for Use

510(k) Number (if known) K192544

Device Name Erchonia Corporation

Indications for Use (Describe)

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K 192544 --- 510(k) Summary

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: Mr. Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia.com

Date Prepared

01/10/2020

Device Information

Trade Name: Erchonia® Emerald Laser Model#: SHL 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

The Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042. Additionally, the Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237.

The principles of operation of the Erchonia® Emerald Laser (Model#: SHL) are identical to the previously cleared Erchonia® SHL Laser (Model# SHL) with the exception of a design change.

4

Reference Device

As part of this 510(k) submission, there is a reference device, which is the Erchonia® Zerona Z6 (Model# SHR) K162578.

The use of the reference device is rationalized as it points to a previous 510(k) application in which an FDA market clearance was granted for overall body contouring with another Erchonia Corporation device (Erchonia® Zerona Z6) that has the same intended use as the subject device; "the non-invasive reduction in fat laver for body contouring."

Device Description

The Erchonia® Emerald (Model#: SHL) is low-level laser system that uses ten (10) semi-conductor diodes (visible green-light) 522nm to 542nm. The Erchonia® Emerald (Model#: SHL) has been classified by the FDA as a Class II device and a Class II Laser in accordance with IEC 60825-1 (Complies with 21 CFR 1040.10 and 21 CFR 1040.11 by laser notice #50. The performance parameters and intended use of the Erchonia® Emerald (Model#: SHL) are compliant to the internationally recognized safety testing standards for medical devices. The Erchonia® Emerald (Model#: SHL) device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 and MDSAP audits. The software incorporated into the operation of the Erchonia® Emerald (Model#: SHL) complies with FDA and ISO Software Development and Validation regulations.

The components of the device include a mobile base that plugs into the wall, using a hospital grade power cord, equipped with a medical-grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to mains power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end-user to alter the laser diode output. The protocol is factory set and cannot be altered by the end-user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the laser head assembly that is attached to the adjustable main arm utilizes internal mechanics that collects the light emitted from each of the ten (10) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly can be manually adjusted for positioning the lasers 3-4 inches from the patient's skin to deliver treatment for body contouring. The device laser head assembly can be moved vertically (raised or lowered) over the subject for proper height placement of lasers for treatment. The device laser head assembly can be moved horizontally (left or right) over the patient for proper placement of lasers for treatment. The device laser head assembly has two adjustable outside laser arms with each arm housing two (2) laser diodes that can be moved in and out for proper positioning to the patient for accurate treatment distance.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI), and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

Device Accessories:

Laser safety glasses (1) Patient & (1) Operator -
-Tape measure
Manual -
Power cord -

5

Assembly Accessories:

Large Screws (2) -
-1/8 (Large) Allen Driver
-Small Screws (4)
1/16 (Small) Allen Driver -
-Wire Cover
Arm Cover -

Intended Use / Indications for Use

The 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

Design Change

The principles of operation of the Erchonia® Emerald (Model# SHL) are identical to the primary predicate device, Erchonia® SHL Laser (Model# SHL), with the exception of a design change. Below is a table that details the comparison of the technology between the subject device and the primary predicate device.

Erchonia® SHL (K142042)	Erchonia® Emerald	Changes
Materials: Kydex T ABS, Acetal,
6061-T6 AL Aluminum	Materials: PT8952 Polyurethane,
Kydex T ABS, Acetal, 6061-T6 AL
Aluminum, 5052 Aluminum	Device enclosure:
updated appearance
The main arm, or boom arm,
adjustment mechanism 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 the Laser
Output Heads for proper
positioning to patient for accurate
treatment distance.
The device is also designed with
an arm lock to manually lock the
main arm adjustment in place.	The main arm adjustment mechanism
is designed using an electric motor
(arm motor). The adjustment of the
main arm is performed by the end user
moving the device arm control switch
(this powers the arm motor). This
allows the end user to lower and raise
the Laser Output Heads for proper
positioning to patient for accurate
treatment distance.
Once a protocol has ended the main
arm will automatically raise up and
away from the patient.	Main arm height
adjustment mechanism:
electric motor with
control switch
Boom Arm: Surgi-Med Solutions

EM 0908.1
Arm Lock (provided w/ Boom
Arm) | Arm Motor: Mcmaster - 6409K18
Control Switch: C&K -
7205J61ZQE22 | |
| Erchonia® SHL (K142042) | Erchonia® Emerald | Changes |
| The PLC & touchscreen are off
the shelf components.
The device has an 8" touchscreen. | The PLC (also known as PCB) is a
custom component, designed
specifically for Erchonia. The
touchscreen is off the shelf. | PLC & touchscreen: |
| PLC: Automation Direct - DL-
205 PLC/D2-06BDC1-1, DL-250-
1, F2-16TD2P, H2-CTRIO
Touchscreen: Automation Direct
EA9-T8 | The device has an 10.4" touchscreen.
PLC: Communication Systems
Solutions - ERCSS4/HPS2 Main
PCB/ER-E-00302
Touchscreen: NLT Technologies -
NL10276BC20-18BD, PTPW10 | custom PLC & larger
touchscreen |
| PSU: Condor/SL Power -
MINT3110A1908K01 | PSU: Condor/SL Power -
MINT3110A0508K01 | AC to DC power supply
(PSU):
a different PSU is
required for power
demands of arm motor,
updated PLC & updated
touchscreen |
| Device is designed with a
mechanical key-switch with a
removable key. The key must be
inserted into the key-switch and
turned to the ON position to
operate the lasers. | Device is designed with 4 digit
passcode within device software. The
correct 4 digit passcode must be
entered into the device software via
the touchscreen to operate the lasers. | Device lockout
mechanism:
passcode within
software |
| Erchonia® SHL (K142042) | Erchonia® Emerald | Areas that Remain
Unchanged |
| 10 | 10 | Quantity of diodes per
device |
| 16mW ± 2mW | 16mW ± 2mW | Power (measured at
aperture) per diode |
| 522nm to 542nm | 522nm to 542nm | Wavelength |
| Multi diode collected then line
dispersed (coherent) | Multi diode collected then line
dispersed (coherent) | Energy Source |
| 0 - 30 minutes | 0 - 30 minutes | Treatment time |
| 288 J | 288 J | Total Joules Per
Treatment |

6

Comparison of Technological Characteristics with the Predicate Device(s)

The Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042. Additionally, the Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS). Additionally, as part of this submission, there is a reference device, which is the Erchonia® Zerona Z6 (Model# SHR) K162578.

The principles of operation of the Erchonia® Emerald Laser (Model#: SHL) are identical to the previously cleared Erchonia® SHL Laser (Model# SHL) with the exception of a design change that was detailed above.

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| Device | Erchonia® Emerald Laser
(Model# SHL) | Erchonia® SHL Laser
(Model# SHL) | Erchonia® Zerona 2.0
(Model# GLS) | Erchonia® Zerona Z6
(Model# SHR) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | Unknown | K142042 | K123237 | K162578 |
| | Subject Device | Primary Predicate | Secondary Predicate | Reference Device |
| Power (measured at aperture) | 16mW ± 2mW | 16mW ± 2mW | 16mW ± 2mW | 17.25mW ± 1.25mW |
| Wavelength | 522nm to 542nm | 522nm to 542nm | 522nm to 542nm | 630nm to 650nm |
| Energy Source | Multi diode collected then line
dispersed (coherent) | Multi diode collected then line
dispersed (coherent) | Multi diode collected then line
dispersed (coherent) | Multi diode collected then line
dispersed (coherent) |
| Treatment time | 0 - 30 minutes | 0 - 30 minutes | 0 - 30 minutes | 0 - 40 minutes |
| Total Joules Per
Treatment | 288 J | 288 J | 173 J | 248 J |
| Power Supply | 100-240VAC, 50-60Hz
electrical outlet | 100-240VAC, 50-60Hz
electrical outlet | 100-240VAC, 50-60Hz
electrical outlet | 100-240VAC, 50-60Hz
electrical outlet |
| Energy Delivery | Floor model device with probe
head | Floor model device with probe
head | Floor model device with probe
head | Floor model device with probe
head |
| 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 | Line pattern, electronically
scanned over area of treatment |
| Indication for Use | The 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 | The Erchonia® SHL Laser is
indicated for use as a non-
invasive dermatological
aesthetic treatment for reduction
of circumference of hips, waist
and upper abdomen when
applied to individuals with a
Body Mass Index (BMI)
between 30 kg/m² and 40 kg/m² | The Erchonia® Zerona™ 2.0
Laser is indicated for use as a
non-invasive dermatological
aesthetic treatment as an adjunct
for individuals intending to
undergo liposuction procedures
for the reductions of
circumference of hips, waist,
and thighs | The Zerona Z6 Laser is
indicated for us as a non-
invasive dermatological
aesthetic treatment for the
reduction of body
circumference |
| Product Code | OLI | OLI | OLI | OLI |
| 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 | Mains power, converted to DC,
powering semi-conductor
diodes |

Comparison of Technological Characteristics with the Predicate Device(s)

8

Performance Data

Compliance with Voluntary Standards

The device complies with the following standards:

Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1:2005 3rd Edition,

General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests IEC 60601-1-2:2014 4th Edition, and

Safety of Laser Products IEC/EN 60825-1:2007 2™ Edition

Performance Standards

The device complies with the FDA's performance standards for light-emitting products (21 CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).

Biocompatibility

Not applicable. The device does not come in contact with the patient's skin or any other bodily tissue.

Sterilization and Shelf-Life

The device is not provided sterile. As an electromechanical device containing no biodegradable materials, such as chemical or biologic, and no mechanical componentry subject to degradation, such as batteries, the aging rationale is based on only the acceptable transportation parameters of time and conditions. The transportation range was assessed by evaluating each component's acceptable temperature and humidity parameters, then identifying an all-inclusive high-low spread. The range noted in the Erchonia® Emerald (Model#: SHL) Owner's Manual was considered and determined acceptable as part of the IEC 60601-1 Safety Testing and is in compliance with the FDA guidance document "Shelf-Life of Medical Devices."

Software Verification and Validation Testing

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 a "minor" level of concern.

Clinical Data

Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237.

Conclusion

Any technological differences between the subject device and predicate do not render the device not substantially equivalent, do not affect the safety or effectiveness, or raise questions regarding the safety and effectiveness due to the fact the total light energy delivered per treatment is equivalent to the predicate(s). The new and predicate device(s) have equivalent technology and provides the same wavelength. The predicate device(s) treatment protocols went through clinical trials to demonstrate that

9

they are safe and effective in providing 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

Therefore, based on the equivalent predicate device(s), the physiological mechanism of action provided by the Erchonia Corporation 532nm diode laser has demonstrated safety and effectiveness to support the proposed indication of use "as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) of up to 40 kg/m²."